The Fixone Meniscal Repair are all-inside meniscal repair devices. Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter. The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage. The device is provided sterile for single use only.

AI/ML Overview

This document describes the performance testing for the "Fixone Meniscal Repair" device. Primarily, it focuses on bench testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy with human subjects.

Here's a breakdown based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various performance tests and their corresponding requirements. However, it does not provide specific numerical results or pass/fail outcomes for each criteria within the summary. It generally states that the tests "demonstrated that the device performs in a substantially equivalent manner to the prior related devices."

Test Item	Requirements	Reported Device Performance
Biocompatibility	Leveraged from K203523 and K230892 for anchor/suture; ISO 10993-1 for other components.	Demonstrated substantial equivalence (implied pass)
Extraction Test	Visual clarity/no foreign particles, pH difference ≤ 1.5, potassium permanganate difference ≤ 2.0 mL, residue after evaporation ≤ 1.0mg, UV spectrum (250-350nm) max absorbance ≤ 0.1, heavy metals not exceeding standard lead solution.	Demonstrated substantial equivalence (implied pass)
Extractable Color (Suture)	MFDS guideline 2021-3 10.non-absorbable suture.	Demonstrated substantial equivalence (implied pass)
EO Residual	ISO 10993-7, Ethylene oxide Sterilization residuals.	Demonstrated substantial equivalence (implied pass)
Sterility Test	ISO 10993-7, Ethylene oxide Sterilization residuals.	Demonstrated substantial equivalence (implied pass)
Comparison Test (Pull-out)	Not explicitly stated, but compared to FAST-FIX Meniscal Repair System and Fixone Meniscal Repair.	Demonstrated substantial equivalence (implied pass)
Comparison Test (Fatigue)	Not explicitly stated, but compared to FAST-FIX Meniscal Repair System and Fixone Meniscal Repair.	Demonstrated substantial equivalence (implied pass)
Shelf Life Testing	Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMI TIR17 and ASTM F 1980-02; Aging temperature: 55±2°C, aging time: 225 days.	Demonstrated substantial equivalence (implied pass)
Comparison Test (Benchtop performance simulating clinical usage)	Not explicitly stated.	Demonstrated substantial equivalence (implied pass)
External Surface	No damage to appearance in visual inspection.	Demonstrated substantial equivalence (implied pass)
Length (Suture)	Not less than 95.0% of 750mm when laid out smooth without tension.	Demonstrated substantial equivalence (implied pass)
Diameter (Suture)	According to MFDS Notification No.2020-20, "Nonabsorbable Surgical Suture, 4. Diameter" with Table 1.	Demonstrated substantial equivalence (implied pass)
Needle Attachment	Meet test requirements of MFDS notification No.2020-97 for "Surgical suture, non-absorbable, with/without needle".	Demonstrated substantial equivalence (implied pass)
Tensile Strength (Knot)	Meet test requirements of MFDS notification No.2020-97 for "Surgical suture, non-absorbable, with/without needle".	Demonstrated substantial equivalence (implied pass)
Endotoxin Test	USP 42 <85>, Bacterial endotoxin test (LAL).	Conducted for each batch; batches not passing are discarded.
Pyrogen Test	USP 42 : 2019, <151> Pyrogen test.	Demonstrated substantial equivalence (implied pass)

2. Sample Size Used for the Test Set and Data Provenance:

The document describes bench testing, not clinical studies with human subjects or test sets in the context of diagnostic accuracy. Therefore, information about patient sample size, country of origin, or retrospective/prospective nature of data for a "test set" is not applicable. The samples used for mechanical and material testing would be device prototypes/production units.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable as the studies described are bench tests of mechanical and material properties, not studies requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies where expert consensus on interpretations is needed.

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:

This information is not provided because an MRMC study is not mentioned. The device is a meniscal repair device, not an AI-powered diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the bench tests would be established through objective engineering and material science standards and measurements. For example, the "ground truth" for tensile strength is a numerical value measured by a testing machine according to a defined protocol. For biocompatibility, it's adherence to ISO 10993 standards and a lack of adverse biological reactions in defined tests.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

Summary

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August 2, 2024

Aju Pharm Co., Ltd. % Peter Chung President Plus Global 300, Atwood Street Pittsburgh, Pennsylvania 15213

Re: K233601

Trade/Device Name: Fixone Meniscal Repair Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: June 18, 2024 Received: June 18, 2024

Dear Mr. Chung:

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" (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).

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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 QS 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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Christopher Ferreira -S

Christopher Ferreira, M.S. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233601

Device Name

Fixone Meniscal Repair

Indications for Use (Describe)

The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.

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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510(k) Summary

1. Applicant

Company : AJU Pharm Co.,Ltd. 1)
1. Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
Tel : 82-31-765-4420 3)
1. Fax : 82-31-602-7818
ട) Prepared date : July 26, 2024
1. Contact person : Peter Chung, 412-512-8802
Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA 7)
Submission type : Traditional 8)

2. Device Information

Trade name : Fixone Meniscal Repair 1)
Common name : Fastener, Fixation, Nondegradable, Soft tissue 2)
Regulation name : Smooth or threaded metallic bone fixation fastener 3)
1. Product code : MBI
Regulation number : 888.3040 ട്)
1. Class of device : Class II
Panel : Orthopedic 7)

3. The legally marketed device to which we are claiming equivalence

Primary Predicate

K153667, DePuy Synthes/ TRUESPAN Meniscal Repair System (Product Code: MBI)

Additional Predicate K121861, Smith & Nephew Inc. / FAST-FIX Meniscal Repair System (Product Code: GAT)

Reference Device K203523, Aju Pharm Co., Ltd / Fixone Hybrid Knotless Anchor (Product Code: MAI) K230892, Aju Pharm Co., Ltd / Fixone Biocomposite Anchor (Product Code: MAI)

4. Device Description

The Fixone Meniscal Repair are all-inside meniscal repair devices.

Each device includes two peek anchors, pre-tied with non-absorbable suture pre-loaded into a needle delivery system with an adjustable length depth limiter.

The device is made to insert into the joint, place and fix the first anchor(T1) around the ruptured meniscus cartilage, and then place and fix the second anchor(T2) to make one Stitch to seal the torn cartilage.

The device is provided sterile for single use only.

5. Intended Use/Indications for Use

The Fixone Meniscal Repair is intended to suture the meniscus tear to facilitate percutaneous or endoscopic soft tissue procedures.

6. Indications for Use Comparison

The indications for use of the Fixone Meniscal Repair are a subset of the predicate device.

7. Technological Characteristics Comparison

The subject device and predicate device both contain PEEK anchors for meniscal repair. The specific design of the anchors, inserter, and suture are different than the predicate.

8. Performance data:

Bench testing included biocompatibility, mechanical testing including EO residues. The tests

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demonstrated that the device performs in a substantially equivalent manner to the prior related devices. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

Biocompatibility of the anchor and suture were leveraged from K203523 and K230892, respectively. Biocompatibility of the other portions of the device were evaluated per ISO 10993-1.

Test item	Requirements	REP NO
	Property	When observing it with the naked eye, testsolution should be clear and have no foreignparticles.	MD2019-00537
	pH	The difference should be 1.5 and less.
Extractiontest	Potassiumpermanganatereducingsubstances	The difference of the consumption of potassiumpermanganate should be 2.0 mL and less.
	Residue afterevaporation	Record the weight of the residue should be 1.0mgand less.
	UVspectrum(250nm~350nm)	Maximum absorbance between 250 to 350 nmshould be 0.1 and less.
	Heavy metals	Any brown color produced within 10 minutes inthe tube containing the extract of the preparedsample does not exceed that in the tube containingthe standard lead solution
	Extractablecolor(Suture)	MFDS guideline 2021-3 10.non-absorbable suture
	EO residual
Sterility test		ISO 10993-7, Ethylene oxide Sterilization residuals	MD2019-00273
Comparisontest	Pull-out	1.Fixone Meniscal Repair	AJU-MD20230728-01
	Fatigue test	2.FAST-FIX Meniscal Repair System	AJU-MD20230728-01
Shelf life testing	Real-time equivalent (RTE) and Accelerated aging temperature, Taa as per AAMITIR17 and ASTM F 1980-02.		AJ-SLR1902(RO)
	Aging temperature: 55±2°C, aging time: 225 days		AJ-SLR1902(RO)
Comparison test	Benchtop performance testing simulating clinical usage		AJU-MD20240613-01(R1)

Test item	Requirements
External surface	The test article shall be no damage to the appearance in visual inspection.
Length	The length of suture was measured while the strand is laid out smooth, without tension, on a plane surface; the length of the strand is not less than 95.0% of 750mm.
Diameter	According to the Technical document (MFDS Notification No.2020-20, "Nonabsorbable Surgical Suture, 4. Diameter") with <Table 1>
Needle attachment	Under the conditions of "Surgical suture, non-absorbable, with/without needle" in notification No.2020-97 of MFDS, the test articles should meet the test requirements.
Tensile strength (Knot)	Under the conditions of "Surgical suture, non-absorbable, with/without needle" in notification No.2020-97 of MFDS, the test articles should meet the test requirements.
EO residual	ISO 10993-7, Ethylene oxide Sterilization residuals
pH	The difference should be 1.5 and less.
Potassium permanganate	The difference of the consumption of potassium permanganate should

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reducing substances	be 2.0 mL and less.
Residue after evaporation	Record the weight of the residue should be 1.0mg and less.
Heavy metals	Any brown color produced within 10 minutes in the tube containing theextract of the prepared sample does not exceed that in the tubecontaining the standard lead solution
UV spectrum(250nm~350nm)	Maximum absorbance between 250 to 350 nm should be 0.1 and less.
Property	When observing it with the naked eye, test solution should be clear andhave no foreign particles.

Endotoxin Test

#	Test item	Test method / Test criteria
1	Endotoxin test	USP 42 <85>, Bacterial endotoxin test (LAL)
2	Pyrogen test	USP 42 : 2019, <151> Pyrogen test

Endotoxin test will be conducted for each batch of product before shipment. The test will be carried out using the Limulus Amebocyte Lysate (LAL) method, recognized by the FDA and internationally. Batches that do not pass the Endotoxin Test will be entirely discarded lots will be documented separately for management purposes. This document will be part of our produce management and quality assurance procedures.

9. Conclusion

The substantial equivalence of the Fixone Meniscal Repair is based on similarities between the intended use, the specifications, and the non-clinical performance testing of the device compared to the legally marketed predicate device. Therefore, it is concluded that Fixone Meniscal Repair is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.