The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is indicated for percutaneous or endoscopic soft tissue procedures which requires usage of a suture retention device. For ex: Meniscus repair.

Device Description

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is an all-inside meniscal repair device with two PEEK non-absorbable polymer implants, preloaded with UHMWPE sutures. SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is preloaded with USP #3-0 UHMWPE suture whereas SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant XL is preloaded with USP #2-0 suture. The adjustable depth control knob is used to define the needle piercing length in the meniscus prior to deployment of the implant. These meniscal repair devices are available in various needle curvature.

AI/ML Overview

The provided document, K230891, describes the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and its substantial equivalence to a predicate device. However, the document does not contain acceptance criteria for the device's performance, nor does it detail a specific study proving the device meets said criteria with the requested level of detail for an AI/ML medical device.

The provided text focuses on the 510(k) submission for a physical medical implant (a suture and PEEK button for meniscus repair) and its comparison to a predicate device, rather than an AI/ML-driven device. As such, information regarding test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established for a training set (all typical for AI/ML device evaluations) are absent.

Here's an analysis based on the information that is available in the document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner (e.g., "pull-out strength must be X N"). Instead, it states the conclusion of the test:

Acceptance Criteria (Implied)	Reported Device Performance
Device performs adequately regarding mechanical strength	SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant performs statistically equivalent to the predicate device.
Device meets pyrogen limit specifications	Bacterial endotoxin per USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications.
Packaging maintains sterile barrier and product integrity	Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified for the pull-out strength, cyclical loading, bacterial endotoxin, or packaging tests.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are non-clinical, likely bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are non-clinical mechanical and biological compatibility tests, not evaluations that require expert interpretation of results to establish ground truth in the context of an AI/ML device.

4. Adjudication method for the test set

Not applicable. This concept is relevant for AI/ML performance ground truth establishment, not for the types of non-clinical tests described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device. The study described compares the subject device's mechanical performance to a predicate device, not human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

For the non-clinical tests described:

Mechanical Performance (Pull-out strength, Cyclical loading): The "ground truth" is measured physical properties and comparison to a predicate device's measured physical properties.
Biological Compatibility (Bacterial Endotoxin): The "ground truth" is adherence to established pyrogen limit specifications (USP <85>).
Packaging: The "ground truth" is the confirmation of sterile barrier integrity and product protection during simulated conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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December 28, 2023

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Healthium Medtech Limited Pankaj Dawar Deputy General Manager Regulatory Affair 472-D. 13th Cross. 4th Phase Peenva Industrial Area Bangalore, Karnataka 560058 India

Re: K230891

Trade/Device Name: SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: November 28, 2023 Received: November 28, 2023

Dear Pankaj Dawar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices

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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) K230891

Device Name

SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant

Indications for Use (Describe)

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)

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Image /page/4/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "SIRONIX" is written in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/4/Picture/1 description: The image contains the text "K230891" in the upper left corner. Below the text is the word "Healthium" in a bold, blue font. To the right of the word is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape in the middle.

1. 510(k) Summary

Submitter Information: 1.1.

Application Correspondent:	PANKAJ DAWARHealthium Medtech Limited472-D, 13th Cross, 4th Phase,Peenya Industrial Area,Bangalore, Karnataka, 560058, INDIA.
Phone:	+91-9886529934
E-mail:	pankaj.d@healthiummedtech.com
Specification Developer:	Healthium Medtech Limited472-D, 13th Cross, 4th Phase,Peenya Industrial Area,Bangalore, Karnataka, 560058, India.
Contact Person	PANKAJ DAWAR
Phone:	+ 91-80-41868000
E-mail:	pankaj.d@healthiummedtech.com
Date Prepared:	27-12-2023

1.2. Device Identification:

Device Trade Name:	SURESTITCH™ UHMWPE Suture PEEK ButtonMeniscus Repair Implant
Device Common Name:	Non-Absorbable Suture Retention Device
Classification Name:	Nonabsorbable poly (ethylene terephthalate) surgicalSuture
Device Class:	Class II
Regulation Number:	21 CFR 888.3040
Product Code:	MBI

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Image /page/5/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The logo consists of the word "SIRONIX" in a bold, sans-serif font, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/5/Picture/1 description: The image contains the text "K230891" at the top left. Below the text is the word "Healthium" in a stylized font. To the right of the text is a logo consisting of two overlapping circles, one orange and one blue, with a white cross shape dividing them into quadrants.

1.3. Predicate Devices:

Device Name	510(k) Number
Smith & Nephew FAST-FIX 360 MeniscalRepair System	K121861

Table 1 – List of Predicate Device

1.4. Device Description

Intended Use & Indications for Use 1.5.

Intended Use

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as, meniscal repair.

Indications for Use

Comparison of Technological Characteristics 1.6.

The fundamental scientific technology, materials of construction and mechamism of operation are similar between the subject device SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and the predicate device. Table 2 summarizes the comparison of technological characteristics between the subject and predicate device.

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Image /page/6/Picture/0 description: The image shows the logo for Sironix. The logo has the word "SIRONIX" in bold, sans-serif font. The "O" in "SIRONIX" is red, while the rest of the letters are black. Below the word "SIRONIX" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

Image /page/6/Picture/1 description: The image contains the alphanumeric string "K230891" in bold, black font at the top left. Below this is the word "Healthium" in a bold, blue font. To the right of the word is a logo consisting of a blue circle with a white cross inside, partially overlapping an orange circle.

Sl.No	Parameters	Smith & Nephew FAST-FIX360 Meniscal Repair System(K121861)	SURESTITCH™ UHMWPESuture PEEK ButtonMeniscus Repair Implant(Subject device)
1.	Manufacturer	Smith & Nephew, Inc	Healthium Medtech Limited
2.	Product Code	GAT	MBI
3.	RegulationNumber	21 CFR 878.5000	21 CFR 888.3040
4.	Classification	Class II	Class II
5.	Intended Use	The FAST-FIX 360 MeniscalRepair System is intended for useas a suture retention device tofacilitate percutaneous orendoscopic soft tissue procedures.The FAST-FIX 360 System isindicated for use in meniscal repairsand allograft transplant procedures.The FAST-FIX 360 System isintended to be used for anchoringthe allograft to the meniscal rimduring allograft transplantprocedures.	The SURESTITCH™ UHMWPESuture PEEK Button MeniscusRepair Implant is intended for useas a suture retention device tofacilitate percutaneous orendoscopic soft tissue proceduressuch as, meniscal repair.
6.	MaterialofConstruction	Implant - PEEKSuture-UHMWPE withmonofilament Polypropylene	Implant - PEEKSuture- UHMWPE
7.	DesignFeature	2-peek implants pretied with non-absorbable suture	2-peek implants pretied with non-absorbable suture
8.	SpecificationsandDimensions	Implant 1:5.00 mm X 0.95 mm (LXD)Implant 2:4.8mmX1.4mmX0.8mm(LXWXH)Delivery Needle: Straight orCurvedSuture Size - USP #2-0	Implant 1:5.50 mm X 0.95 mm (L X D),Implant 2:6.4(max) mm X 0.95 mm (L X D),Delivery Needle: LEFT, RIGHT,UP, DOWNSuture Size - USP #3-0Implant 01 XL:5.50 mm X 1.2 mm (L X D),Implant 02 XL:6.4(max) mm X 1.2 mm (L X D)Delivery Needle: LEFT, RIGHT,UP, DOWNSuture Size - USP #2-0
SI.No	Parameters	Smith & Nephew FAST-FIX360 Meniscal Repair System(K121861)	SURESTITCH™ UHMWPESuture PEEK ButtonMeniscus Repair Implant(Subject device)
9.	Shelf Life	3 Years	5 Years
10.	SterilizationMethod	EtO	EtO
11.	PerformanceData	Pull-out strength,Cyclical loading	Pull-out strength,Cyclical loading
12.	Safety Data	No data available	• Skin Sensitization• Intracutaneous reactivity• Material Mediated Pyrogenicity• Acute Systemic Toxicity• In vitro cytotoxicity• Bone Implantation• Muscle Implantation• Bacterial Endotoxin

Table 2 – Substantial Equivalence Table

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Image /page/7/Picture/0 description: The image shows the logo for Sironix Arthroscopy Solutions. The word "Sironix" is written in a bold, sans-serif font, with the "O" in "Sironix" being a red circle. Below the word "Sironix" is the phrase "Arthroscopy Solutions" in a smaller, sans-serif font.

K230891

Image /page/7/Picture/2 description: The image contains the text "K230891" in the upper left corner. Below this text is the word "Healthium" in a bold, sans-serif font. To the right of the text is a logo consisting of two overlapping circles, one blue and one orange.

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Image /page/8/Picture/0 description: The image shows the logo for Sironix. The logo has the word "SIRONIX" in bold, with the "O" in "SIRONIX" being a red circle. Below the word "SIRONIX" is the text "Arthroscopy Solutions".

Image /page/8/Picture/1 description: The image contains the alphanumeric string "K230891" in the upper left corner. Below the alphanumeric string is the word "Healthium" in a bold, sans-serif font. To the right of the word is a logo consisting of a blue circle with a white cross in the center, partially overlapping an orange circle.

Summary of Performance Data 1.7.

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant and Predicate device underwent tests to determine their pull-out strength and cyclical loading. Results demonstrated that the SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant performs statistically equivalent to the predicate device FAST-FIX 360 meniscal repair system.

1.8. Non-Clinical Testing

The Static pull out testing and cyclic loading were performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.

Bacterial endotoxin per USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications.

Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.

1.9. Conclusion

The SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant is substantially equivalent to the predicate devices. Any differences between the subject device and the predicate devices do not raise questions concerning safety and effectiveness.

Based on the indications for use, technological characteristics, and the summary of data submitted, It is determined that the proposed device is substantially equivalent to the currently marketed predicate devices.

Regulation Number and Section

N/A