(102 days)
ORTHOCORD Suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Violet #2) absorbable polydioxnone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.
The provided document is a 510(k) summary for the ORTHOCORD Suture and does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. This type of document is a regulatory submission for medical devices that demonstrates substantial equivalence to a legally marketed predicate device, rather than a detailed report of clinical or performance studies with specific acceptance criteria.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Conformance to USP monograph for absorbable sutures | Device conformed to the USP monograph for absorbable sutures. |
| Substantial equivalence to predicate devices (PDS II suture, FiberWire suture) | Determination of substantial equivalence was based on a detailed device description, and conformance to consensus and voluntary standards. The device was shown to be substantially equivalent to predicate devices. |
Missing Information: Specific quantitative acceptance criteria (e.g., tensile strength thresholds, degradation rates, knot security values) are not provided in this 510(k) summary. The document broadly states "conformance to consensus and voluntary standards" and "USP monograph for absorbable sutures" as the basis for performance.
2. Sample size used for the test set and the data provenance
Missing Information: The document states "Non-clinical laboratory testing was performed" but does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typically contained in the full testing report, not the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable: For a suture device, "ground truth" established by experts as in an image-based diagnostics study is not relevant in the same way. Performance is typically assessed through laboratory testing against established physical and mechanical standards.
4. Adjudication method for the test set
Not Applicable: See point 3.
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 a physical medical device (suture), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable: See point 5.
7. The type of ground truth used
For a suture, "ground truth" would be established by:
- Physical and Mechanical Standards: Measurements against the USP monograph for absorbable sutures, and other consensus/voluntary standards (e.g., tensile strength, knot pull strength, degradation profile, biocompatibility, sterility). These standards themselves define what "truth" means for a functional suture.
- Comparison to Predicate Devices: Performance characteristics were compared to already approved predicate devices (PDS II suture and FiberWire suture) to demonstrate substantial equivalence.
8. The sample size for the training set
Not Applicable: As a physical medical device, there is no "training set" in the context of machine learning or AI models. Performance is evaluated through laboratory testing of the manufactured product.
9. How the ground truth for the training set was established
Not Applicable: See point 8.
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KO4OOOY
P/2
APR 1 3 2004
SECTION 2 – 510(k) SUMMARY
ORTHOCORD Suture
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Ruth C. ForstadtSenior Regulatory Affairs AssociateDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-3188Facsimile: 781-278-9578e-mail: rcforstad@ethus.jnj.com |
| Name of Medical Device | Classification Name:Non-absorbable poly(ethylene terephthalate)surgical suture; andCommon/Usual Name:Suture, Surgical, Absorbable, PolydioxanoneSutureProprietary Name:ORTHOCORD Suture |
| Substantial Equivalence | ORTHOCORD Suture is substantially equivalent to:PDS II suture (N18331) manufactured by Ethicon, Inc. and FiberWiresuture (K010673) manufactured by Arthrex, Inc. |
| Device Classification | Sutures are classified by the FDA as Class II Medical Devices.PDS Suture carries an FDA product code NEW, and is classified asabsorbable surgical suture, polydiaxanone under 21 CFR 878.4840.Polyethylene suture carries an FDA product code GAT, and is classifiedunder 21 CFR 878.5000. |
| Device Description | ORTHOCORD suture is a synthetic, sterile, braided composite suturecomposed of dyed (D&C Violet #2) absorbable polydioxnone (PDS)and un-dyed non-absorbable polyethylene. The partially absorbablesuture is coated with a copolymer of 90% caprolactone and 10%glycolide. |
Confidential
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KOYOOOY
P2/2
ORTHOCORD Suture is indicated for use in general soft tissue Indications for Use approximation and/or ligation, including use in orthopedic surgeries. The determination of substantial equivalence for this device was based Safety and Performance on a detailed device description, and conformance to consensus and voluntary standards. Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures. Based on the indications for use, technological characteristics, and comparison to predicate devices, the Mitek ORTHOCORD Suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Public Health Service
APR 1 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K040004
Trade/Device Name: Orthocord Suture Regulation Number: 21 CFR 878.4840, 878.5000 Regulation Name: Absorbable PDS suture, Nonabsorbable polyethylene suture Regulatory Class: II Product Code: NEW, GAT Dated: March 31, 2004 Received: April 1, 2004
Dear Mrs. Forstadt:
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 (sec 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Ruth C. Forstadt
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 entifled, "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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Koyoooy
Indications for Use
510(k) Number (if known): K040000
Device Name: ORTHOCORD Suture
Indications for Use:
ORTHOCORD Suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Prescription Use
(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)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K040004
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.