(76 days)
The Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears.
The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.
The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture. The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers).
This document is a 510(k) summary report for the Stryker Mini-Mender Meniscal Repair System, which is a medical device and not a software algorithm or AI device. Therefore, many of the requested categories related to acceptance criteria and study design for software performance (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable.
Here's an analysis based on the provided text, focusing on the device's regulatory pathway and the criteria for its marketing clearance:
Acceptance Criteria and Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device and adherence to relevant standards and guidance documents. The device performance is assessed in terms of its ability to meet these equivalence criteria and comply with safety and efficacy guidelines for surgical sutures and instruments.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Compliance |
|---|---|---|
| Intended Use Equivalence | Intended for passing suture through soft tissue for suture fixation of meniscal tears; for single-use applications. | "The Stryker Mini-Mender Meniscal Repair System is intended to pass suture through soft tissue for suture fixation of meniscal tears." "The Stryker Mini-Mender Meniscal Repair System is intended for single-use only." Substantially equivalent to predicate device (Linvatec SharpShooter Meniscal Repair System) in intended use. |
| Technological Characteristics Equivalence | Device consists of pre-curved cannulas, double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture, and disposable introducers. | Described components match exactly: "a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture. The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers)." |
| Material Compliance (Suture) | Non-absorbable, braided polyester surgical suture; conforms to USP Section XXV - Nonabsorbable Surgical Sutures. | Suture specified as "USP non-absorbable, braided polyester surgical suture." "conforms to USP Section XXV - Nonabsorbable Surgical Sutures." Suture sourced from manufacturers with FDA clearance (e.g., Genzyme Biosurgery/Teleflex Medical, K021019). |
| Sterility | Sterilized by Gamma irradiation; validated to a sterility assurance level (SAL) of 10^-6. | "The device will be sterilized by Gamma irradiation (EN 552) and validated to a sterility assurance level (SAL) of 10^-6." "provided pre-assembled, sterile for single-use applications (ASTM 4169)." |
| Biocompatibility | Biocompatible per ISO-10993 and G95-1. | "The device is biocompatible per ISO-10993 and G95-1." |
| Predicate Device Equivalence | Substantially equivalent to the Linvatec SharpShooter Meniscal Repair System. | "The Stryker Mini-Mender Meniscal Repair System is considered substantially equivalent to the Linvatec SharpShooter Meniscal Repair System." FDA's letter confirms: "determined the device is substantially equivalent... to legally marketed predicate devices." |
| Special Controls/Guidance | Adherence to Class II Special Controls Guidance Document: Surgical Sutures issued on June 3, 2003. | "adherence to the Class II Special Controls Guidance Document: Surgical Sutures issued on June 3, 2003." "conforms to... the Class II Special Controls Guidance Document: Surgical Sutures issued on June 3, 2003." |
Details Regarding Study/Evaluation (For a non-AI/software device)
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
For a physical medical device like this, there isn't a "test set" in the sense of a dataset for an algorithm. Rather, the device undergoes specific engineering, material, and biological testing to ensure it meets the required standards. The document doesn't specify sample sizes for these tests (e.g., how many sutures were tested for tensile strength, how many devices for sterility, etc.), but it implicitly states these tests were conducted to demonstrate compliance with standards like USP, ISO-10993, EN 552, and ASTM 4169. Data provenance is not specified but would typically be from in-house or contracted laboratory testing in the country of manufacture or testing. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable (N/A). The "ground truth" for this device is established by adherence to recognized medical device standards and regulations, rather than expert interpretation of a clinical dataset. Compliance is assessed by regulatory bodies (FDA) and manufacturers through established testing protocols. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
N/A. Adjudication methods are relevant for clinical trials or diagnostic performance studies involving human interpretation. For this physical device, compliance is based on meeting pre-defined physical, chemical, and biological specifications. -
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:
N/A. This is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies are not relevant. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This device is a physical surgical tool, not an algorithm. Its performance is inherent in its design, materials, and manufacturing, and it is used by a human surgeon. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's clearance is established through compliance with recognized standards and regulations. Specifically:- Predicate device's safety and efficacy: The Linvatec SharpShooter Meniscal Repair System serves as a basis for determining substantial equivalence, implying its established safe and effective use.
- USP Section XXV - Nonabsorbable Surgical Sutures: A pharmacopeial standard detailing requirements for surgical sutures.
- ISO-10993 (Biocompatibility): International standard for biological evaluation of medical devices.
- EN 552 (Sterilization): European standard related to sterilization of medical devices.
- ASTM 4169 (Sterility packaging): Standard for sterility assurance and packaging.
- Class II Special Controls Guidance Document: Surgical Sutures: FDA guidance document outlining specific controls for this device type.
- Clinical acceptance of meniscal repair with suture: The submission explicitly states suture repair is the "Gold Standard" and "has been well published in professional journals."
-
The sample size for the training set:
N/A. This is a physical device, not an AI model. There is no "training set" in this context. -
How the ground truth for the training set was established:
N/A. As there is no training set, this question is not applicable.
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DEC = 2 2003
K03290/
P.1/2
ABBREVIATED 510(k)
SUMMARY REPORT OF SAFETY AND EFFECTIVENESS AND ADHERENCE TO THE CLASS II SPECIAL CONTROLS GUIDANCE DOCUMENT: SURGICAL SUTURES ISSUED ON JUNE 3, 2003
Device Name
The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture, The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers),
| Classification Name: | Cannula, Surgical, General & Plastic Surgery |
|---|---|
| Device Classification: | 21 CFR §878.4800, Class I - Exempt |
| Common and Usual Name: | Cannula (GEA) |
| Classification Name: | Passer, Wire, Orthopedic |
| Device Classification: | 21 CFR §888.4540, Class I - Exempt |
| Common and Usual Name: | Passer (HXI) |
| Classification Name: | Non-Absorbable Poly(ethylene terephthalate) Surgical Sutures |
| Device Classification: | 21 CFR §878.5000, Class II |
| Common and Usual Name: | Polyester Nonabsorbable Surgical Sutures (GAT) |
| Proprietary Name: | Stryker Mini-Mender Meniscal Repair System |
Predicate Devices
Linvatec SharpShooter Meniscal Repair System, currently marketed by Linvated CONMED (Largo, FL).
Guidance Document
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA issued on June 3, 2003
Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990 and of the Special Controls as defined in section 513(a)(1)(B) of the Act for an Abbreviated 510(k).
The Stryker Mini-Mender Meniscal Repair System is intended to pass suture through soft tissue for suture fixation of meniscal tears. The use of suture to repair meniscus tears is common, considered the "Gold Standard" in meniscal repair, and has been well published in professional journals such as Operative Techniques in Orthopaedics and The American Journal of Sports Medicine (See Tab 1)
The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture. The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers),
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KU72901/P2/2
Stryker will acquire suture from a suture manufacturer that has received FDA clearance for the suture, such as Genzyme Biosurgery/Teleflex Medical (510(k) #K021019), with an intended use as specified for the Mini-Mender Meniscal Repair System. Stryker will assemble the Introducer and sterilize (reprocess) the device/suture prior to market release.
The Stryker Mini-Mender Meniscal Repair System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Gamma irradiation (EN 552) and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO-10993 and G95-1. The Stryker Mini-Mender Meniscal Repair System is substantially equivalent in intended use, safety, and efficacy to the predicate device and conforms to USP Section XXV - Nonabsorbable Surgical Sutures and the Class II Special Controls Guidance Document: Surgical Sutures issued on June 3, 2003.
The Stryker Mini-Mender Meniscal Repair System is considered substantially equivalent to the Linvatec SharpShooter Meniscal Repair System.
Contact:
82
Date: Aug. 29, 2003
Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 (408) 754-2000 x.2148
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, which are meant to represent the flow of people and services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2003
Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K032901 Trade/Device Name: Stryker Mini-Mender Meniscal Repair System Regulation Number: 21 CFR 878.5000, 21 CFR 888.4540 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture, Orthopedic manual surgical instrument Regulatory Class: II, I Product Code: GAT, LXH Dated: August 20, 2003 Received: September 17, 2003
Dear Ms. Murphy:
We have reviewed your Section 510(k) promarket 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. 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.
If your device is classified (scc above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Melissa Murphy
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by refercnce to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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August 20, 2003
Ko3290/
510(k) Number if known:_
INDICATION FOR USE:
The Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears.
The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Division of General, Restorative and Neurological Devices
510(k) Number K032901
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use _
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.