SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
K231073 · Esthetic Medical, Inc. · QAI · Jul 28, 2023 · General, Plastic Surgery
Device Facts
Record ID
K231073
Device Name
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Applicant
Esthetic Medical, Inc.
Product Code
QAI · General, Plastic Surgery
Decision Date
Jul 28, 2023
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4430
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
Device Story
Handheld microneedling device; 1A DC motor; rapidly reciprocates 36-needle array (304 18/8 surgical steel); creates microinjuries in skin. Powered by rechargeable lithium-ion battery or AC wall adapter. Features depth adjustment dial (0.0mm to 2.5mm); removable nosecone interface; disposable single-use cartridge. Used in clinical settings by trained professionals. Cartridge design and nosecone interface prevent fluid ingress into motor body. Device improves scar appearance via mechanical tissue injury. No software component.
Clinical Evidence
No clinical trial conducted. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), sterilization validation (ISO 17665, ISO 11737), fluid ingress, shelf-life, electrical safety (IEC 60601), and mechanical performance (depth/rate validation).
Technological Characteristics
Handheld device; 304 18/8 surgical steel needles; anodized aluminum body; 1A DC motor. Depth range 0.0-2.5mm. Power: 5V DC battery or AC adapter. Sterilization: Gamma ray (cartridges), autoclave (nosecone). Biocompatibility per ISO 10993; metallurgical analysis per ASTM E1019-11. No software.
Indications for Use
Indicated for adults aged 22+ to improve appearance of surgical or traumatic hypertrophic abdominal scars and facial acne scars in Fitzpatrick skin types I, II, and III.
Regulatory Classification
Identification
A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.
Special Controls
The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested: (i) Accuracy of needle penetration depth and puncture rate; (ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and (iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use. Performance data must demonstrate the sterility of the patient-contacting components of the device. Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device. Software verification, validation, and hazard analysis must be performed for all software components of the device. The patient-contacting components of the device must be demonstrated to be biocompatible. Performance data must validate the cleaning and disinfection instructions for reusable components of the device. Labeling must include the following: (i) Information on how to operate the device and its components and the typical course of treatment; (ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate; (iii) Validated methods and instructions for reprocessing of any reusable components: (iv) Disposal instructions; and (v) Shelf life. Patient labeling must be provided and must include: (i) Information on how the device operates and the typical course of treatment; (ii) The probable risks and benefits associated with use of the device; and (iii) Post-operative care instructions.
*Classification.* Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.
Predicate Devices
Collagen P.I.N. (Percutaneous Induction Microneedling) System (K222199)
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July 28, 2023
Esthetic Medical Inc. % Marc Sanchez Regulatory Attorney Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave NW Suite 1025 Washington, District of Columbia 20006
Re: K231073
Trade/Device Name: SkinStylus SteriLock® MicroSystem, Model Number MP1209SL Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: May 12, 2023 Received: May 12, 2023
Dear Marc Sanchez:
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.
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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 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 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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.07.28
13:54:57 -04'00'
Mark Trumbore, 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
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### Indications for Use
510(k) Number (if known)
Device Name SkinStylus SteriLock® MicroSystem
#### Indications for Use (Describe)
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
Type of Use (*Select one or both, as applicable*)
| <div> <span style="padding-right: 5px;"></span> <label><span style="font-size: 10pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span></label> </div> | <div> <span style="padding-right: 5px;"></span> <label><span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span></label> </div> |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
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## 5. 510(K) Summary
The following information is provided as required by 21 CFR 807.92 for the SkinStylus SteriLock® MicroSystem 510(k) premarket notification.
| Sponsor: | Esthetic Medical Inc.<br>Attention: Lawrence Groop<br>7950 E. Acoma Drive Suite 208<br>Scottsdale, AZ 85260<br>Establishment Registration: 3011338460 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | GUANGZHOU CARAIN BEAUTY EQUIPMENT<br>103 & 601, No. 3 of Xin Liu Mu Road,<br>Zhong Cun Street<br>Guangzhou Guangdong, CHINA 511495<br>Establishment Registration: 3011568699 |
| Contact: | Marc C. Sanchez, Esq.<br>Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)<br>1717 Pennsylvania Ave NW Suite 1025 Washington D.C. 20006<br>Ph: 202.765.4491<br>E-mail: msanchez@fdaatty.com) |
| Date of Submission: | July 28, 2023 |
| Proprietary Name: | SkinStylus SteriLock® MicroSystem |
| Common Name: | Powered Microneedle Device |
Regulation Number: 21 CFR 882.4810
Regulatory Class: Class II
Product Code: QAI
Predicate Device(s): Collagen P.I.N. (Percutaneous Induction Microneedling) System (K222199).
#### Device Description:
The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles.
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Traditional 510k Submission SkinStylus SteriLock® MicroSystem
The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.
The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.
The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use.
The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge.
The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached.
Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy under report #GM2015012518. Certifications on file with sponsor and available for review.
### Intended Use:
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
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#### Summary of Clinical Test Reports
A new clinical trial was not conducted to support the additional indications for use and overall safety of the device.
#### Non-Clinical Test Reports
The following tests were performed on the SkinStylus SteriLock® MicroSystem device and the test results show that the subject device is substantially equivalent to the predicate Device.
| Test Completed | Standard |
|---------------------------|------------------------------------------------------------------------------------------------------------------|
| BiocompatibilityA | Cytotoxity - ISO 10993-5:2009 |
| | Sensitization -ISO 10993-10:2010 |
| | Irritation - Intracutaneous Injection Test GLP - ISO<br>10993-10:2010 |
| | Systemic Toxicity – Systemic Injection GLP - ISO<br>10993-11:2017 |
| | Pyrogenicity ISO 10993 |
| | Metallurgical Analysis – GLP - ASTM E1019-<br>11(Method A)(C/S Analyzer) |
| Sterilization ValidationB | Sterilization of Health Care Products - Moist heat<br>ISO 17665-1:2006 |
| | Sterilization of Medical Devices ISO 11737-1: 2006 |
| | Sterilization of Medical Devices ISO 11737-2: 2009 |
| | Sterility and Bacteriostasis/Fungistasis Tests ISO<br>11737-2: 2009 and USP 71 |
| Reprocessing ValidationB | ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMI<br>TIR-12:2004) |
| Fluid Ingress ValidationB | SkinStylus Sterilock Microsystem Leak<br>Testing Report from MicroChem Laboratories |
| Shelf-life TestingB | Standard Test Method for Seal Strength of Flexible<br>Barrier Materials ASTM F88/F88M-15 |
| | Standard Test Method for Detecting Seal Leaks in<br>Porous Medical Packaging by Dye Penetration<br>ASTM F1929-15 |
#### Table 1 Summary of Non-Clinical Performance Testing
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| | Standard Test Method for Microbial Ranking of<br>Porous Packaging Materials ASTM F1608-16 |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Electrical Safety and Electromagnetic<br>CompatibilityC | IEC 60601-1-2 and 60601-1 |
| Depth Penetration ValidationD | Internal Method - Depth Penetration Report |
| Needle Reciprocal Rate Validation | Internal Method - Needle Reciprocal Rate Report |
| Clinician Usability Study | Internal Method - Usability Report |
| A Mitigation measure for adverse tissue reaction. | |
B Mitigation measure for cross-contamination and infection.
C Mitigation measure for electrical shock or electromagnetic interference with other devices.
D Mitigation measure for Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to exceeding safe penetration depth or mechanical failure. **
**NOTE: The proposed device contains NO software
#### Summary of Substantial Equivalence
The SkinStylus SteriLock® MicroSystem and the predicate are for similar uses and rely on the same mode of action. Both devices include disposable needle cartridges with design features to mitigate the likelihood of cross-contamination between patients and to prevent needle depth greater than 2.5mm. Both devices also include a redundant safety feature to ensure no fluid enters the motor or housing.
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| Table 2 |
|-------------------------------|
| Technological Characteristics |
| Technological Characteristics | | | | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name/Model | SkinStylus SteriLock®<br>MicroSystem<br>Subject Device | Collagen P.I.N.<br>(Percutaneous Induction<br>Microneedling) System<br>Predicate Device | SkinStylus SteriLock®<br>MicroSystem<br>Reference Device | Comments |
| 510(k)<br>Number | K231073 | K222199 | K200044 | N/A |
| Indication for<br>Use | The SkinStylus SteriLock® MicroSystem<br>is intended to be used as a treatment to<br>improve the appearance of surgical or<br>traumatic hypertrophic scars on the<br>abdomen in adults aged 22 years or older.<br>The SkinStylus SteriLock® MicroSystem<br>is a microneedling device and accessories<br>intended to be used as a treatment to<br>improve the appearance of facial acne<br>scars in Fitzpatrick skin types I, II, and III<br>in patients aged 22 years and older. | Intended to be used as a<br>treatment to improve the<br>appearance of facial acne<br>scars in Fitzpatrick skin<br>types I-III in patients<br>aged 22 years and older | Intended to be used as<br>a treatment to improve<br>the appearance of<br>hypertrophic<br>abdominal scarring | Subject device<br>same as predicate<br>device |
| Mode of<br>Action | Microneedling (using<br>one or more needles to<br>mechanically puncture<br>and injure skin tissue for<br>aesthetic use) | Microneedling (using one<br>or more needles to<br>mechanically puncture and<br>injure skin tissue for<br>aesthetic use) | Microneedling (using<br>one or more needles to<br>mechanically puncture<br>and injure skin tissue for<br>aesthetic use) | Same |
| Power Source<br>1 | 5 Volt DC/1 amp<br>rechargeable<br>lithium-ion battery | 5 Volt DC/1 amp<br>rechargeable lithium-ion<br>battery | 5 Volt DC/1 amp<br>rechargeable lithium-ion<br>battery | Same |
| Power Source<br>2 | AC Adapter 5VC<br>+/-, 1A minimum | AC Adapter 5VC +/-,<br>1A minimum | AC Adapter 5VC<br>+/-, 1A minimum | Same |
| Range of<br>Needle Length | 0.0-2.5mm | 0.0mm-3.0mm | 0.0-2.5mm | - Similar to<br>predicate device<br>-Needle penetration<br>of subject device is<br>.5mm less than<br>predicate device<br>which has been<br>cleared to 3.0mm |
| Maximum<br>Penetration | 2.5mm | 3.0mm | 2.5mm | - Similar to<br>predicate device<br>-Needle penetration<br>of subject device is<br>.5mm less than<br>predicate device<br>which has been<br>cleared to 3.0mm |
| Needle<br>Geometry | 36 solid needles | 36 solid needles | 36 solid needles | Same |
| Speed | 6200- 8840 RPM | 7000 RPM-9000 RPM | 6200- 8840 RPM | Negligible<br>difference in RPM<br>Does not impact<br>the safety or<br>efficacy of the<br>subject device |
| Cross<br>Contamination<br>Safety Feature | Cartridge design and<br>intermediate disinfected<br>handpiece and nosecone<br>with optional reprocessed<br>(autoclave sterilized)<br>nosecone; | Cartridge design and<br>intermediate disinfected<br>handpiece and nosecone<br>with optional reprocessed<br>(autoclave sterilized)<br>nosecone; | Cartridge design and<br>intermediate disinfected<br>handpiece and nosecone<br>with optional<br>reprocessed (autoclave<br>sterilized) nosecone; | Same |
| Sterility and<br>Cleaning | Disposable cartridge<br>Gamma Ray Sterilized<br>prior to packaging | Disposable cartridge<br>Ethylene Oxide Sterilized<br>prior to packaging | Disposable cartridge<br>Gamma Ray Sterilized<br>prior to packaging | Both devices use<br>approved methods<br>for cartridge<br>sterilization.<br>Does not impact<br>the safety or<br>efficacy of the<br>subject device |
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# Traditional 510k Submission
SkinStylus SteriLock® MicroSystem
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Traditional 510k Submission SkinStylus SteriLock® MicroSystem
#### Conclusion:
Therefore, taking into consideration Table 2 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the SkinStylus SteriLock® MicroSystem raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device. Further, the predicate device has been cleared for 3.0mm needle penetration, whereas the subject device (and already cleared reference device) has a maximum needle penetration of only 2.5mm.
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.
