(78 days)
MaxBraid™ Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation
Two configurations of MaxBraid™ suture are included in this submission. The first consists of a polyester core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyester Plus Suture. The second type consists of a polyethylene core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyethylene Plus Suture. Both types are supplied in lengths of 38" with or without attached suturing needles. The suture is size 2 in keeping with currently recognized United States Pharmacopoeia (USP) standards. Both white and blue suture will be marketed. The suture is coated with silicone in order to ease passage through tissue. When desired, the MaxBraid™ Polyester Plus and Polyethylene Plus Suture may be used with a commercially available suture anchor.
The provided text is a 510(k) summary for the MaxBraid™ Suture, which is a medical device. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with detailed performance metrics.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used (beyond general "USP standards")
- Sample size for the training set
- How ground truth for the training set was established
The document explicitly states: "Clinical Testing: None provided." This indicates that no clinical studies were performed, which would be the typical source for the detailed performance data requested.
Instead, the document states:
- Non-Clinical Testing: "Testing demonstrated that MaxBraid™ Suture met or exceeded the USP 24 standards for nonabsorbable sutures and are substantially equivalent to the predicate devices."
This means the acceptance criteria are adherence to USP 24 standards for nonabsorbable sutures, and the "study" demonstrating this involves non-clinical (i.e., bench or lab) testing. However, the specific metrics, their measured values, sample sizes, and detailed methodology of these non-clinical tests are not provided in this 510(k) summary.
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FEB 1 2 2004
K033718
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Image /page/0/Picture/2 description: The image shows the logo for ARTHROTEK, a Biomet Company. The logo is in black and white, with the word "ARTHROTEK" in large, bold letters. The "O" in ARTHROTEK is a solid black circle. Below the word "ARTHROTEK" is the phrase "A Biomet Company" in smaller letters.
CORPORATE HEADOL ARTERS
510(k) Summary
Applicant/Sponsor: Arthrotek, Inc.
Patricia Sandborn Beres Contact Person: Senior Requiatory Specialist Biomet Manufacturing Corp.
Proprietary Name: MaxBraid™ Polvester Plus and Polyethylene Plus Suture
Classification Name: Suture, nonabsorbable, synthetic, polyethylene (21 CFR 878.500)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Arthrex FiberWIRE™ -K010673 (Arthrex, Inc.) and Polyester Nonabsorbable Surgical Suture - K001172 (CP Medical)
Device Description: Two configurations of MaxBraid™ suture are included in this submission. The first consists of a polyester core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyester Plus Suture. The second type consists of a polyethylene core with a braided polyethylene and polyester outer layer with the trade name of MaxBraid™ Polyethylene Plus Suture. Both types are supplied in lengths of 38" with or without attached suturing needles. The suture is size 2 in keeping with currently recognized United States Pharmacopoeia (USP) standards. Both white and blue suture will be marketed. The suture is coated with silicone in order to ease passage through tissue. When desired, the MaxBraid™ Polyester Plus and Polyethylene Plus Suture may be used with a commercially available suture anchor.
Intended Use: MaxBraid™ Polyester Plus and Polyethylene Plus Sutures are indicated for general soft tissue approximation and/or ligation
Summary of Technologies: The overall design, materials and processing are similar to the predicate device.
Non-Clinical Testing: Testing demonstrated that MaxBraid™ Suture met or exceeded the USP 24 standards for nonabsorbable sutures and are substantially equivelent to the predicate devices.
Clinical Testing: None provided
All trademarks are property of Biomet, Inc. FiberWIRE is a trademark of Arthrex, Inc.
MAILING ADDRESS 56 E. Bell Drive Warsaw, IN 46581 0587
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EMAIL Arthrotek@Arthrotek.com
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או אין 1974 319.372.1718
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2004
Arthrotek, Inc. c/o Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0578
Re: K033718
Trade/Device Name: MaxBraid™ Polyethylene Plus and Polyester Plus Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(cthylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: November 25, 2003 Received: November 26, 2003
Dear Ms. Beres:
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. 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 (see 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 Fedcral 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Patricia Sandborn Bercs
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, pcrmits your device to proceed to the market.
If you desire spccific 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 reference 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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Indications for Use
510(k) Number (if known): K033718
Device Name: MaxBraid™ Polyethylene Plus and Polyester Plus Suture
Indications For Use: MaxBraid™ Polyethylene Plus and Polyester Plus suture is indicated for general soft tissue approximation and/or ligation
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K633718
§ 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.