K221783 · Nsp Tech Pte, Ltd. · FMK · Oct 24, 2022 · General, Plastic Surgery
Device Facts
Record ID
K221783
Device Name
SafetiCET Safety Lancet
Applicant
Nsp Tech Pte, Ltd.
Product Code
FMK · General, Plastic Surgery
Decision Date
Oct 24, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Indications for Use
The device is designed for obtaining capillary blood sample.
Device Story
SafetiCET is a single-use, sterile blood lancet with an integral sharps injury prevention feature. It consists of a needle encased in a plastic housing with a protective cap. Operation: user removes the protective cap via a twist-break mechanism; device is placed against the patient's skin; contact activation triggers a spring-loaded mechanism that pushes the needle out to pierce the skin; a return spring automatically retracts the needle into the housing post-penetration, rendering the device inoperable to prevent reuse and needlestick injuries. Used in clinical or home settings for diagnostic blood sampling. The device ensures sterility and safety through its encapsulated design and automatic retraction mechanism.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing, including sterilization validation (ISO 11137-1), biocompatibility (ISO 10993), penetration depth, twist-break force, drop testing, joint strength, puncture resistance, and needle retraction testing.
Indicated for obtaining capillary blood samples for diagnostic purposes in patients requiring blood collection.
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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
10/24/2022
NSP Tech Pte Ltd Hc Tan Operations Manager 10 Admiralty Street, Northlink Building, #02-06 Singapore, 757695 Singapore
Re: K221783
Trade/Device Name: SafetiCET (SC-150);SafetiCET (SC-180);SafetiCET (SC-220);SafetiCET (SC-250);SafetiCET (SC-250B) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: August 29, 2022 Received: September 1, 2022
Dear Hc Tan:
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
{1}------------------------------------------------
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,
for Long Chen, Ph.D. 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
{2}------------------------------------------------
## Indications for Use
510(k) Number (if known) K221783
Device Name SafetiCET Safety Lancet
| Indications for Use (Describe) | The device is designed for obtaining capillary blood sample. |
|--------------------------------|--------------------------------------------------------------|
|--------------------------------|--------------------------------------------------------------|
| 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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K221783
## 510(k) Summary SafetiCET Blood Lancet
#### SUBMITTER: 1.
## Applicant Name:
NSP Tech Pte Ltd 10 Admiralty Street, Northlink Building, #02-06 Singapore 757695
## Contact Person:
| Name | : HC Tan |
|-------|--------------------------------|
| Phone | : (65)98180450 |
| Fax | : (65)67476533 |
| Email | : hockchoon.tan@nsptech.com.sg |
| Establishment registration number | | |
|-----------------------------------|--|--|
| | | |
3008337059
Date prepared
: 21st October 2022
## 2. DEVICE
| Trade Name | : | SafetiCET Safety Lancet |
|---------------------|---|-----------------------------------------------------------------------------------|
| Common Name | : | Blood Lancet |
| Regulatory Class | : | Class II (special controls) |
| Classification Name | : | Single Use Only Blood Lancet with an Integral<br>Sharps Injury Prevention Feature |
| Product Code | : | FMK |
| Regulation Number | : | 21 CFR § 878.4850 (special controls) |
| Review Panel | : | General & Plastic Surgery |
| Device 510K number | : | K221783 |
#### PREDICATE DEVICE 3.
VeriFine Safety Lancet Regulatory Class II Product Code FMK General & Plastic Surgery Predicate device 510K number: K221368
#### DEVICE DESCRIPTION: 4.
The SafetiCET Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a needle encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use.
{4}------------------------------------------------
NSP Tech Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for SafetiCET
## 510(k) Summary SafetiCET Blood Lancet
The SafetiCET Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means.
## 5. INTENDED USE
The device is used for obtaining capillary blood sample.
## 6. INDICATION FOR USE STATEMENT
The device is designed for obtaining capillary blood sample.
# 7. SUBSTANTIAL EQUIVALENCE COMPARISON
## TABLE OF COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE
| | SafetiCET Safety Lancet | VeriFine Safety Lancet |
|-----------------------|------------------------------------------------------------------|-------------------------------------------------|
| 510 (k) Number | K221783 | K 221368 |
| Classification | Class II | Class II |
| Product Code | FMK | FMK |
| Intended Use | The device is designed for<br>obtaining capillary blood sample. | It is intended for capillary blood<br>sampling. |
| Indication For<br>Use | The device is designed for<br>obtaining capillary blood samples. | It is intended for capillary blood<br>sampling. |
| Manufacturer | NSP Tech Pte Ltd | Promisemed Hangzhou Meditech<br>Co., Ltd. |
| Sterilizer | Grandten | Not known |
| Needle Gauge | 21G, 23G, and 28G | 18G, 21G, 23G, 25G, 26G, 28G,<br>30G |
{5}------------------------------------------------
## 510(k) Summary SafetiCET Blood Lancet
| | SafetiCET Safety Lancet | VeriFine Safety Lancet |
|----------------------|---------------------------------------------------------------------------------------------|-------------------------------|
| Sterilization | Gamma Radiation sterilization | Gamma Radiation sterilization |
| Sterility | Meet the Sterility Assurance Level<br>of 10-6 as per the requirement of<br>ISO 11137-1:2006 | Not known |
| Use | Single-Use only | Single-Use only |
| Bio<br>compatibility | ISO 10993 series | ISO 10993 series |
| Shelf Life | 5 years | Not mentioned |
# 8. TECHNOLOGICAL CHARACTERISTICS COMPARISON
The SafetiCET Safety Lancet has similarities with the predicate device in areas such as Intended Use, Indications For Use, Sterilization means.
The results of measuring penetration depth of the subject device are in the same range of the needle length of the predicate device. There is no significant difference in technological characteristics between the subject device and the predicate device.
Performance tests and comparison tests on the device quality confirmed the safety and effectiveness of the device.
In summary, the subject device and predicate device are said to have same technological characteristics.
{6}------------------------------------------------
## 510(k) Summary SafetiCET Blood Lancet
## 9. PRODUCT SAFETY AND EFFECTIVENESS DATA
| Product Safety<br>Design and<br>Effectiveness | The housing of the device encases the Needle and device has a<br>protective cap attached to the housing. This combination prevents any<br>needle stick issue with user or patient before the device is activated.<br>The safety relating to needle stick issue is further enhanced with the<br>needle encapsulated by a plastic molded over it when residing in the<br>housing of the device. This encapsulation is only removed when the<br>protective cap is detached from the housing with a force known as the<br>Twist Break Force preparing the device for activation and use. The<br>encapsulation of the needle also allows it to remain sterile after the<br>device has undergone sterilization process. This prevents any<br>inadvertent pathogen contamination or contact to user or patient before<br>use.<br><br>The device is activated by pushing the device on the blood collection<br>area of the patient. Once activated, the needle is pushed out of the<br>housing by the Trigger Spring. After the device has performed the<br>piercing or penetration operation, the Return Spring pushes the needle<br>back into the housing preventing any needlestick issue. The Trigger<br>Spring helps in attaining the effectiveness of the device in providing the<br>penetration operation essential for the blood sample collection. The<br>Return Spring helps in accomplishing the safety of the device by<br>ensuring that the needle retracts into the housing after the penetration<br>operation is completed. |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Principle | Both the subject device and the predicate device adopt the same test<br>operation principle of capillary blood sample collection. The device is<br>first placed on the blood collection area of the patient and using contact<br>activation means, the automatic mechanism is activated with the<br>needle coming out of the device housing to make the piercing or<br>penetration operation. After the penetration operation is completed, the<br>needle automatically retracts into the housing. Because of the<br>construction of the mechanism, the needle cannot be pushed out of the<br>housing for a second round of penetration preventing the device from<br>being reused. After use, the device is to be discarded in a suitable<br>biohazard container.<br><br>The blood collection operation is controlled for its depth of the<br>penetration. This is done by the design of the parts operating in the<br>device. Hence, the device is checked for Penetration Depth as part of<br>its performance assessment.<br><br>The protective cap is able to break the encapsulation of the needle<br>when the twisting force is applied on the cap. This twisting force also<br>allows the cap to be detached from the housing preparing the device<br>for the penetration operation. Here, the Twist Break Force is measured<br>as part of device performance assessment. |
{7}------------------------------------------------
## 510(k) Summary SafetiCET Blood Lancet
## 10. PERFORMANCE TESTING SUMMARY
The following performance testing done on the subject device is compared against that of the predicate device.
- Sterilization testing and Validation ●
- . Penetration depth test
- Twist break force test ●
- Drop test
- Joint strength of needle-to-needle holder test ●
- Joint strength of top cover to housing test ●
- Puncture resistance test ●
- Needle retraction test ●
- Mechanical properties test of material
#### 11. CONCLUSION
The comparison and evaluation of the device features, intended use, indication for use statement, and performance tests demonstrate substantial equivalence between the subject device and the predicate device. For the Safety and Effectiveness test, the subject device provides same safety and effective performance as the predicate device. From the evaluation above, we can deem that the Safety Lancet is substantially equivalent to the predicate device.
Predicate graph will load when search results are available.
Embedding visualization will load when search results are available.
PDF viewer will load when search results are available.
Loading panels...
Select an item from Submissions
Click any panel, subpart, regulation, product code, or device to see details here.
Section Matches
Results will appear here.
Product Code Matches
Results will appear here.
Special Control Matches
Results will appear here.
Loading collections...
Loading
My Alerts
You will receive email notifications based on the filters and frequency you set for each alert.
Sort by:
Create Alert
Search Filters
Agent Token
Create a read-only bearer token for Claude, ChatGPT, or other agents that can call HTTP APIs.
Copy this now. It will not be shown again.
Connected apps
Apps you authorized through browser sign-in. Disconnecting revokes their access immediately.
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.
