K222303 · Owen Mumford, Ltd. · FMK · Oct 25, 2022 · General, Plastic Surgery
Device Facts
Record ID
K222303
Device Name
Unistik® Pro
Applicant
Owen Mumford, Ltd.
Product Code
FMK · General, Plastic Surgery
Decision Date
Oct 25, 2022
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4850
Device Class
Class 2
Indications for Use
The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.
Device Story
Unistik Pro is a sterile, single-use, hand-held safety lancet for controlled fingertip skin puncture to obtain capillary blood specimens. Device features integral sharps protection (shielded needle before/after use) to prevent needlestick injuries and automatic self-disabling mechanism to prevent reuse. Available in 21G, 25G, and 28G needle variants with specific penetration depths (1.2mm–2.0mm). Operated by manual rear-fire button; spring-powered lancing and needle retraction. Used by patients, caregivers, or clinicians in home or clinical environments for IVD diagnostic regimes. Output is a capillary blood sample for diagnostic testing. Benefits include standardized, safe, and controlled blood collection with reduced risk of sharps injury and cross-contamination.
Clinical Evidence
Bench testing only. No clinical data presented. Design verification testing confirmed needle retention, penetration depth, sharps injury protection, activation force, cap removal torque, and drop test performance met internal specifications.
Technological Characteristics
Materials: Stainless steel needle, plastic housing, steel spring. Principle: Spring-powered, manually activated (rear button) lancing with automatic needle retraction. Sterilization: Electron beam irradiation (25-60 kGy) to SAL 10^-6 per ISO 11137. Biocompatibility: Compliant with ISO 10993. Form factor: Hand-held, single-use disposable.
Indications for Use
Indicated for patients requiring capillary blood samples for in-vitro diagnostic assays (e.g., blood glucose monitoring) in home or clinical settings. Suitable for self-testing patients, caregivers, and healthcare professionals.
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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10/25/2022
Owen Mumford Ltd % Patty Cronan Quality Manager Owen Mumford USA Inc. 1755 West Oak Commons Ct. Marietta, Georgia 30062
Re: K222303
Trade/Device Name: Unistik® Pro Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: July 27, 2022 Received: August 1, 2022
Dear Patty Cronan:
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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 medical devices and radiation-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
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K222303
Device Name Unistik Pro
Indications for Use (Describe)
The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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# SECTION 5.0
# 510(k) SUMMARY
# 1. Submitter
| Prepared by: | Owen Mumford Ltd<br>Tel: +44(0)1993 812021<br>Fax: +44(0)1993 813466 |
|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared for: | Owner/ Operator<br>Owen Mumford Ltd<br>Brook Hill<br>Woodstock<br>Oxfordshire<br>OX20 1TU<br>United Kingdom<br>Establishment Registration Number: 3003348846 |
| Contact Person: | Darren Mansell<br>Regulatory Affairs Manager<br>Owen Mumford Ltd,<br>Tel: +44(0)1993 812021<br>Fax: +44(0)1993 813466<br>Email: darren.mansell@owenmumford.com |
| Date Prepared: | 27th July 2022 |
| 2. Device | |
| 510(k) Number:<br>Name of Device:<br>Common Name:<br>Classification Name:<br>Regulatory Class:<br>Product Code: | K222303<br>Unistik® Pro<br>Blood lancets<br>Single use only blood lancet with an integral sharps<br>injury prevention feature<br>FMK |
# 3. Predicate Devices
| Predicate Device Name: | SurgiLance® Safety Lancet, under 510k number K101145. |
|------------------------|----------------------------------------------------------|
| | (Cleared for: Prescription Use and Over-The-Counter Use) |
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#### 4. Description of The Device
The Unistik® Pro is a sterile single-use safety lancet, a hand-held disposable device intended to be used to achieve a controlled skin puncture on the fingertip, in order to obtain a capillary blood specimen. The Unistik® Pro sterile single-use safety lancets are indicated for use where a capillary blood specimen is required for the purposes of performing in-vitro diagnostic (IVD) assays, e.q., for blood glucose monitoring in patients with diabetes,
The Unistik® Pro safety lancets are available in 3 different variants, each with a different needle gauge (21G, 25G and 28G with penetration depths of 2.0mm, 1.6mm and 1.2mm respectively) as required by the patient.
The Unistik® Pro sterile single-use safety lancets are designed for prescription and over-thecounter use and to be used by self-testing patients, care-givers and healthcare professionals. The devices are designed to perform a controlled skin puncture on the finqertip, in order for caregivers and healthcare professionals to obtain capillary blood specimens from patients for IVD assays, and also for lay (home) users to be able to perform a skin puncture on themselves where an IVD self-testing regime is required. The intended user population includes male and female, right or left-handed self-administering patients, care givers and healthcare professionals. The frequency of use and intended patient population is dependent on the given diagnostic regime.
The Unistik® Pro sterile single-use safety lancets feature integral sharps protection whereby the lancet needle is shielded before and after use to prevent needlestick injuries, so mitigating the hazard of transmission of blood-borne infectious agents. Furthermore, the device automatically self-disables after a single use, thus preventing any hazards of re-use.
The purpose of these 510(k) applications is to obtain both prescription-only clearance and overcounter clearance for the Unistik® Pro sterile single-use safety lancets. The intended use for the Unistik® Pro sterile single use safety lancets is similar and substantially equivalent to the predicate device.
Note: The Unistik® Pro was previously produced for Owen Mumford by Artaplast, and as such some of the documentation supplied to support this submission may reference the company "Artaplast". In addition, in Artaplast documentation the device may be referred to as the following previously used names: "Carelance Micro Flow", "Optilance Micro Flow", "Arta Lancet". In some Owen Mumford documentation, Unistik Pro may be referred to as "Unistik Protop". All of the references listed in this note can be considered to refer to the Unistik Pro device produced by Owen Mumford Ltd for the entirety of this submission.
### 5. Indications for Use
The intended user is any patient that needs to obtain capillary samples at home/clinical environment. Unistik Pro is a single-use lancet used to obtain a capillary blood sample.
#### 6. Technological Characteristics
The Unistik® Pro sterile single-use safety lancets are substantially equivalent to the predicate device, the SurgiLance® Safety Lancet, 510(k) number K101145.
A comparison of the intended uses and technological characteristics of the Unistik® Pro sterile single-use safety lancets to the predicate SurgiLance® devices is summarized in table 5.1 below.
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Table 5.1 A comparison of the device characteristics between the predicate and submission devices
| Device Characteristic | Predicate Device:<br>SurgiLance® Safety<br>Lancets - K101145. | Submission Device -<br>Unistik® Pro sterile single-use<br>safety lancets | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SurgiLance® Safety<br>Lancet is a skin puncture<br>device to obtain micro blood<br>samples.<br>The SurgiLance® Safety<br>Lancet has a sharps<br>prevention feature to protect<br>the user from needlestick<br>injuries. | The intended user is any patient<br>that needs to obtain capillary<br>samples at home/clinical<br>environment. Unistik Pro is a<br>single-use lancet used to obtain a<br>capillary blood sample.<br>Therefore, substantially equivalent<br>to the predicate device | |
| Use environment | Home and clinical | Home and clinical | |
| Operating principle | Contact-activated spring-<br>powered automatic lancing<br>and needle retraction. | Manually activated (rear fire button)<br>spring-powered automatic lancing<br>and needle retraction. | |
| Design/ construction | Stainless steel lancet needle<br>moulded into a plastic lancet<br>holder component, which in<br>turn is assembled into a<br>moulded plastic outer<br>housing with a pre-loaded<br>steel spring | Similar to the predicate device,<br>consisting of stainless steel lancet<br>needle moulded into plastic lancet<br>holder component, assembled into<br>a moulded plastic outer housing<br>with a steel spring, additionally with<br>a plastic rear firing button | |
| Integral sharps injury prevention<br>feature? | Yes | Unchanged from the predicate<br>device | |
| Single-use? | Yes | Unchanged from the predicate<br>device | |
| Sterility | Sterile | Unchanged from the predicate<br>device | |
| Components and Materials | Plastic external and internal<br>components, stainless steel<br>needle and steel spring | Unchanged from the predicate<br>device, but likely that plastic and<br>steel specifications used differ from<br>predicate. | |
| Package | Laminate pulp board cartons | Unchanged from the predicate<br>device. | |
| Device Characteristic | | Predicate Device:<br>SurgiLance® Safety<br>Lancets – K101145. | Submission Device -<br>Unistik® Pro sterile single-use<br>safety lancets |
| Needle<br>Specifications | Needle<br>Gauges<br>(SWG) | 18G, 21G | 21G, 25G and 28G<br>The predicate device is available in<br>18G and 21G variants only,<br>therefore the Unistik® Pro sterile<br>single-use safety lancets represent<br>an extended range of higher<br>gauges (smaller needle diameters)<br>compared to the predicate. |
| | Lancing<br>Depths (mm) | 1.8 mm & 2.3 mm (18G)<br>1.0 mm, 1.8 mm, 2.2 mm &<br>2.8 mm (21G) | 2.0mm (21G), 1.6mm (25G) and<br>1.2mm (28G)<br>The Unistik® Pro sterile single-use<br>safety lancets lancing depth range<br>falls within the range offered by the<br>predicate device, i.e. 1.2mm –<br>2.0mm (Unistik Pro) compared to<br>the predicate range of 1.0mm – 2. |
| | Sterilisation<br>method | Not known. | 25-60 kGy electron beam irradiation<br>validated to achieve a sterility<br>assurance level (SAL) of 10-6. |
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## 7. Performance Data
#### Non-clinical performance data:
Design verification testing of the Unistik® Pro sterile single-use safety lancets has been carried out to evaluate the performance of the devices against defined acceptance criteria.
The following table provides a summary of the relevant design verification testing.
### Bench Testing:
| Test | Requirement | Results |
|---------------------------------------------------------|-----------------------------|---------------------|
| Needle Retention Force | Internal test specification | Meets specification |
| Depth of Penetration | Internal test specification | Meets specification |
| Sharps Injury Protection | Internal test specification | Meets specification |
| Button Activation Force | Internal test specification | Meets specification |
| Cap Removal Torque | Internal test specification | Meets specification |
| Drop test (as part of sharps injury<br>protection test) | Internal test specification | Meets specification |
Table 5.1: Summary of the performance tests performed on Unistik Pro
The devices comply with the acceptance criteria established based on the specifications of the devices. All additional performance tests met the acceptance criteria.
The results from these tests demonstrate that the Unistik® Pro sterile single-use safety lancets are safe and effective when used as intended.
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#### Biocompatibility:
Based on available information and biocompatibility reports available for the device and its components, Owen Mumford concludes that the device meets all requirements according to ISO 10993 and FDA guidance when used as intended.
Please see Section 15 - Biocompatibility for more information.
#### Sterilisation:
The sterility of the devices is assured using a sterilisation method validated in accordance with ISO 11137 "Medical Devices – Validation and Routine Control of Radiation Sterilisation". Through the sterilisation methods used, all devices are sterilised to provide a Sterility Assurance Level (SAL) of 10-6.
Sterilization Method: Electron beam irradiation Radiation dose range: 25-60 kGy Sterility assurance level (SAL): 10-6
#### Shelf life
The Unistik® Pro sterile barrier has been qualified for 5 years, but Owen Mumford is currently submitting Unistik Pro with a 2.5-year shelf life, with a plan to supplement this submission with accelerated-aged functional testing data in the near future. For more information see Section 18 – Performance Testing.
#### 8. Conclusion
In summary, the differences between the Unistik® Pro sterile single-use safety lancets and the predicate device have no impact on safety and effectiveness and the products are therefore substantially equivalent to the predicate device.
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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.
