K221383 · Shanghai Carelife International Trading Co. , Ltd. · QRK · Sep 21, 2022 · General, Plastic Surgery
Device Facts
Record ID
K221383
Device Name
MedtFine Blood Lancet
Applicant
Shanghai Carelife International Trading Co. , Ltd.
Product Code
QRK · General, Plastic Surgery
Decision Date
Sep 21, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Attributes
Pediatric
Indications for Use
MedtFine Blood Lancet is intended for use together with a lancing device for puncture of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
Device Story
MedtFine Blood Lancet; sterile, single-use, double-edged needle device; used for capillary blood sampling via fingerstick or alternative sites. Device consists of needle sheath, hub, and needle; sterilized via gamma radiation. Intended for use with universal lancing devices; user removes sheath and loads lancet into lancing device. Device punctures skin to obtain small blood specimens for diagnostic monitoring. Used in home or clinical settings by patients or healthcare providers. Output is a drop of capillary blood; facilitates blood glucose or other diagnostic testing. Benefits include ease of use and reduced puncture force compared to predicates, potentially minimizing patient pain.
Clinical Evidence
No clinical data. Bench testing only, including physical performance (ISO 9626, ISO 7864, ISO 11608), sterility validation (ISO 11137, ISO 11737), and biocompatibility (ISO 10993, USP <71>, <85>, <788>).
Technological Characteristics
Materials: SUS 304 needle, PP hub, PE sheath. Dimensions: 28G, 30G, 33G. Sterilization: Gamma radiation (SAL 10^-6). Standards: ISO 9626 (needle tubing), ISO 7864 (sterile needles), ISO 11608 (injection systems), ISO 10993 (biocompatibility), ASTM F1980 (aging), ASTM F1929 (packaging).
Indications for Use
Indicated for children older than 2 years, adolescents, and adults for capillary blood sampling via skin puncture when used with a compatible lancing device.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
*Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
*Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
*e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
*e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
*1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
*2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
*Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
*Classification.* Class III (premarket approval).(3)
*Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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September 21, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Shanghai Carelife International Trading Co. Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China
Re: K221383
Trade/Device Name: MedtFine Blood Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: August 18, 2022 Received: August 23, 2022
Dear Evan Hu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin Chen Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K221383
Device Name MedtFine Blood Lancet
Indications for Use (Describe)
MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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# K221383 510(K) SUMMARY
### 1. Preparation date: 9/16/2022
### 2. Submitter
Manufacturer: Shanghai Carelife International Trading Co. Ltd. Address: 1707 Yinqiao Bldg.,58 Jinxin Rd.201206 Shanghai, PEOPLE'S REPUBLIC OF CHINA person: Xiaoying, Quality Contact zxy@shanghaicarelife.com Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net
### 3. Device
Trading name: MedtFine Blood Lancet Common name: Sterile Blood Lancet Classification Name: Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature Classification: Class II Product code: QRK
### 4. Predicate device
Primary predicate device: Promisemed Blood Lancet - K192666 Reference device: Accu-Chek Softclix Blood Lancing System - K214022
#### 5. Device description
MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens.
The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color.
The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.
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Table 1. Device models
| Gauge Size | Designated metric size | Color |
|------------|------------------------|-------------|
| 28G | 0.36 | Green-Blue |
| 30G | 0.30 | Grey-Blue |
| 33G | 0.20 | Transparent |
- 6. Indications for use/Intended use
MedtFine Blood Lancet is intended for use together with a lancing device for puncture of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
- 7. Comparison of technological characters between proposed and predicate devices
| Characters | Proposed device<br>(K221383- MedtFine Blood Lancet) | Primary predicate<br>device<br>(K192666-Promisemed<br>Blood Lancet) | Reference device<br>(K214022- Accu-Chek<br>Softclix Blood Lancing<br>System) | Remark | Type of use | over-the-counter | over-the-counter | over-the-counter | Same |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------------------------------|-----------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Product code | QRK | FMK | QRL, QRK | #1 | Configuration<br>and materials | Needle sheath: PE<br>Hub: PP<br>Needle: SUS 304 | Cap: PE<br>Body: PE<br>Needle: SUS | Cap<br>Body<br>Needle | #6 |
| Regulation No. | 21 CFR 878.4850 | 21 CFR 878.4800 | 21 CFR 878.4850 | #2 | Needle Gauge | 28G, 30G, 33G | 21G, 26G, 28G, 30G | 28G | #7 |
| Classification | Class II | Class I | Class II | #3 | Sterility | Sterilized by gamma<br>radiation<br>SAL = $10^{-6}$ | Sterilized by gamma<br>radiation<br>SAL = $10^{-6}$ | Sterilized by gamma<br>radiation<br>SAL = $10^{-6}$ | Same |
| Intended use | MedtFine Blood Lancet is<br>intended for use together<br>with a lancing device for<br>puncture of skin to obtain<br>a drop of capillary blood<br>from fingertip or from<br>alternative sites. | It is intended for<br>capillary blood<br>sampling. | The Accu-Chek Softclix<br>Blood Lancing System is<br>intended for the hygienic<br>collection of capillary<br>blood for testing<br>purposes from the side of<br>a fingertip and from<br>alternative sites, such as<br>the palm, the upper arm,<br>and the forearm. | #4 | Single-use | Single use on one patient,<br>no more than one use | Single use on one<br>patient, no more than<br>one use | Single use on one patient,<br>no more than one use | Same |
| Indications for<br>use | | | Accu-Chek Softclix<br>Lancets:<br>The sterile, single-use<br>lancets are to be used<br>with the reusable lancing<br>device that is to be<br>cleaned and disinfected<br>between each use, and<br>then the lancets are to be<br>disposed of. | #5 | Sharp injury<br>protection | No sharp injury protection<br>function | No sharp injury<br>protection function | Lancets are covered by a<br>sterile barrier cap until<br>twisted off before use.<br>Until firing, the lancet is<br>contained within the<br>lancing device housing.<br>Immediately after firing,<br>the lancet is<br>automatically retracted<br>back into housing. An<br>ejector sleeve can then<br>be pulled forward for<br>contactless disposal of<br>the lancet | #8 |
| Intended<br>population | Child older than 2 years<br>Adolescent<br>Adult | Adult | Not known | #9 | | | | | |
| Visual<br>inspection | (a) Smooth, clean,<br>free from contamination<br>(b) No color fading<br>(c) Sharp edge, free<br>from burrs, hook, and<br>blunt.<br>(d) Straight, no<br>slanting<br>Meet visual checking<br>requirements of ISO 9626,<br>ISO 7864, and internal<br>requirements | Meet visual checking<br>requirements of ISO<br>9626 and ISO 7864 | Not known | #10 | | | | | |
| Needle<br>dimension- | 33G: 3.47 mm<br>30G: 3.52 mm | 21G: 3mm<br>26G: 3mm<br>28G: 3mm | Not known | #11 | | | | | |
Table 2. Characters comparison
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| exposed needle<br>length | 28G: 3.25 mm | 30G: 3mm | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------|------|
| Needle<br>dimension-OD | 33G: 0.20 mm<br>30G: 0.32 mm<br>28G: 0.36 mm<br>Meet needle outer<br>dimension requirements<br>of ISO 9626 | Meet needle outer<br>dimension<br>requirements of ISO<br>9626 | Not known | Same |
| Chemical<br>Characters | Limits for acidity or<br>alkalinity<br>33G: 0.31<br>30G: 0.29<br>28G: 0.34<br>Meet requirements of ISO<br>7864 | Meet requirements of<br>ISO 7864 | Not known | Same |
| Needle bond<br>force | 33G: 12.15 N<br>30G: 15.87 N<br>28G: 15.39 N<br>Meet requirements of ISO<br>7864 | Meet requirements of<br>ISO 7864 | Not known | Same |
| Resistance to<br>corrosion | No corrosion in NaCl<br>solution for 7 hours<br>Meet corrosion resistance<br>requirements of ISO 9626 | Meet corrosion<br>resistance<br>requirements of ISO<br>9626 | Not known | Same |
| Lancing device<br>compatibility | As a universal device, it is<br>compatible with various<br>commercially marketed<br>lancing devices verified in<br>usability testing. | It claims to be<br>compatible with<br>lancing devices. | It claims to be compatible<br>with the Accu-Chek<br>Softclix Blood Lancing<br>System | Same |
| Penetrate<br>force/puncture<br>force | 33G: 0.388 N<br>30G: 0.543 N<br>28G: 0.545 N<br>Meet requirements of ISO<br>7864 | 30G: 0.656 N<br>28G: 0.751 N<br>Meet requirements of<br>ISO 7864 | Not Known | #12 |
| Biocompatibility | No hemolysis<br>No cytotoxicity<br>No irritation and no skin<br>sensitization<br>No acute systemic toxicity<br>No pyrogens | No cytotoxicity<br>No irritation and no<br>skin sensitization | Not Known | #13 |
## #1, #2 and #3:
Single-use only blood lancet without an integral sharps injury prevention feature was once a Class I device exempted from 510(k) registration. However, the regulation was last amended, and the device is reclassified to Class II, effective on 12/03/2021. The device is given the
{7}------------------------------------------------
product code QRK under regulation 21 CFR part878.4850. So, the differences are administrative differences, which cannot affect the device's safety and effectiveness.
The reference device is a combination device that consists of a lancet and a lancing device. In this case, only the lancet is used to be compared. So, there is no difference in product code, requlation number, and classification.
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
### #4 and #5
There is no difference of intended use and indication for use between the proposed device and the primary predicate device. They are both intended to equip with a lancing device and then puncture the skin to obtain capillary blood.
However, the reference device is a combination system, and only the lancet is compared. For this view, there is also no difference.
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
### #6:
The configurations are different. The proposed device has a removable needle sheath (or called a cap). The user could directly remove the needle sheath and load it to a lancing device. However, the primary and reference devices have an integrity structure, which means the cap, body, and needle are over-molded together from an injection machine. The user should twist the cap to expose the needle and the load to a lancing device. The differences are rising from the different manufacturing processes. So, the process validation and device performance testing are run to verify the device's effectiveness.
The materials used are different. Due to the integrity structure, the primary predicate and reference devices only use PE to make the cap and body. However, the proposed device uses PE to make the sheath (cap) and PP to make the hub (cap) due to two separated manufacturing processes and late assembly. So, biocompatibility testing is run to verify the device's safety.
The proposed device uses SUS 304 to make a needle; however, the predicate device does not reveal the exact stainless-steel grade. The difference between different SUS grades is their performance. So, performance testing is conducted to verify the device's effectiveness.
In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
### #7:
The proposed device has three types of gauge, more than the primary and reference device. The primary predicate device has four types, according to their official website, and the reference device only has one type. So, all proposed device types' performance testing is run to verify the device's effectiveness.
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In conclusion, the proposed device, primary predicate, and reference devices are substantially equivalent.
#8:
Unlike the reference device, the proposed and predicate devices do not claim sharp injury protection features, meaning they don't contain the sharp injury prevention structure. It cannot affect safety and effectiveness.
#9: The intended population of the proposed device is wider than the primary predicate device. So, the manufacturer conducts population evaluation testing, and the results support the intended population, demonstrating substantial equivalence.
#10: The proposed device uses an additional internal requirement to conduct the device's visual checking to confirm no deficiencies in visual appearance. The internal requirements are derived from the visual checking sections of ISO 9626 and ISO 78664. The visual checking results meet all requirements, so there is no significant difference compared with the predicate device, demonstrating substantial equivalence.
#11: The needle length of the proposed device is slightly longer than the predicate device. Testings of performance and usability show no impact of a slightly longer needle on device properties because the exposed needle length is tuned by the lancing device, not the lancet itself, demonstrating the substantial equivalence.
#12: The proposed device's penetrate force (puncture force) is lower than the primary predicate device, meaning that the proposed device lancet is easier to puncture into the patient's skin, resulting in a less painful feeling for patients. Results show that the proposed device is comparable to the predicate device in the penetrate force, demonstrating substantial equivalence.
#13: The proposed device conducts six items of biocompatibility testing, but the predicate device only conducts three items. Results show that the proposed device is as safe as the proposed device, demonstrating substantial equivalence.
- 8. Non-clinical testing results
The non-clinical tests of this proposed device are tested in conformance with the following standards.
- (1) Physical performance testing
- (a) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
- (b) ISO 7864-2016 Sterile hypodermic needles for single use requirements and test methods
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- (c) ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods - Part 1: Needle-based injection systems
- (d) ISO 11608-2 Needle-based injection system s for medical use — Requirements and test methods — Part 2: Double-ended pen needles
- (2) Sterility
- (a) ISO 11737-1:2018, Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
- (b) ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- (c) ISO 11137-1:2006, Radiation sterilization of medical devices part 1: Requirements for the development, validation and routine control of the sterilization process of medical devices.
- (d) ISO 11137-2:2013, Radiation sterilization of medical devices part 2: Determination of sterilization dose.
- (e) ISO11137-3 : 2006 Radiation sterilization of medical devices part 3: Dosage guidelines.
- (f) ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
- (q) ISO 11607-2:2019, Packaqing for terminally sterilized medical devices--Part 2: Validation requirements for forming, sealing and assembly processes
- (h) ASTM F1980: Standard for Accelerated Aging of Sterile Barrier Systems and Medical Devices
- (i) ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- (j) ASTM D4169-16 Standard Practice For Performance Testing Of Shipping Containers And Systems
- (k) USP <71> Sterility Test
- (3) Biocompatibility testing
- (a) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- (b) ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
- (c) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- (d) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
- (e) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
- (f) USP <85> Bacterial Endotoxins Test
- (q) USP <788>Particulate matter in injection
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- (h) USP <161>Medical Devices-Bacterial endotoxin and pyrogen tests
### 9. Clinical testing
No clinical testing is available for this device.
# 10. Conclusion
The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
