(10 days)
Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Blue ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Blue #6) absorbable polydioxanone (PDS) and un-dyed non-absorbable polyethylene. The partially absorbable suture is coated with a copolymer of 90% caprolactone and 10% glycolide.
1. Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a medical device (Blue ORTHOCORD suture) and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or reporting detailed performance metrics against those criteria in the format typically found for diagnostic or interventional devices with quantifiable outcomes like accuracy, sensitivity, or specificity.
For medical sutures, "acceptance criteria" and "device performance" are typically evaluated against established consensus standards and the USP monograph for absorbable sutures. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to consensus and voluntary standards. | Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures. |
| Substantial equivalence to predicate devices (Violet ORTHOCORD suture and PDS II suture) based on technological characteristics and indications for use. | Based on the indications for use, technological characteristics, and comparison to predicate devices, the Blue ORTHOCORD suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act. |
2. Sample Size and Data Provenance
The document describes non-clinical laboratory testing. For such testing, the concept of "test set" in the context of diagnostic AI models is not directly applicable. The "sample size" would refer to the number of sutures tested for various properties (e.g., tensile strength, knot security, degradation profile). However, the specific sample sizes used for the non-clinical laboratory testing are not provided in this 510(k) summary.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, as these distinctions are more relevant for clinical studies with human subjects or real-world data collection. The testing was "non-clinical laboratory testing."
3. Number of Experts and Qualifications for Ground Truth
This document does not involve the establishment of "ground truth" by human experts in the way an AI diagnostic study would. The performance of a suture is determined through objective, standardized laboratory tests (e.g., against USP monographs). Therefore, there were no experts used to establish ground truth in this context. The "ground truth" is defined by the technical specifications of the materials and the performance parameters set by regulatory and industry standards.
4. Adjudication Method
Since no human experts were involved in establishing ground truth, there was no adjudication method used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is typically conducted for diagnostic devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. A suture is a physical medical device, not an interpretive one.
6. Standalone (Algorithm Only) Performance Study
No standalone performance study (algorithm only) was done. The device is a physical suture, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" in this context is based on objective measurements derived from non-clinical laboratory testing against established specifications and standards, specifically the USP monograph for absorbable sutures. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI product would be.
8. Sample Size for Training Set
There is no concept of a "training set" for this device. A training set is used to train machine learning models. This is a physical medical device, not an AI or software algorithm.
9. How Ground Truth for Training Set Was Established
As there is no training set, this question is not applicable.
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DEC 1 0 2004
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510(k) SUMMARY
Blue ORTHOCORD suture
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 | |
|---|---|---|
| Contact Person | Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy 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:Common/Usual Name:Proprietary Name: | Non-absorbable poly(ethylene terephthalate)surgical suture; andSuture, Surgical, Absorbable, PolydioxanoneSutureBlue ORTHOCORD suture |
| Substantial Equivalence | Blue ORTHOCORD suture is substantially equivalent to:Violet ORTHOCORD suture (K040004) manufactured by Mitek; andPDS II suture (N18331) manufactured by Ethicon, Inc. | |
| Device Classification | Sutures, classified by the FDA, are 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 | Blue ORTHOCORD suture is a synthetic, sterile, braided compositesuture composed of dyed (D&C Blue #6) absorbable polydioxanone(PDS) and un-dyed non-absorbable polyethylene. The partiallyabsorbable suture is coated with a copolymer of 90% caprolactone and10% glycolide. | |
| Indications for Use | Blue ORTHOCORD suture is indicated for use in general soft tissueapproximation and/or ligation, including use in orthopedic surgeries. | |
| Safety and Performance | The determination of substantial equivalence for this device was basedon a detailed device description, and conformance to consensus andvoluntary standards. Non-clinical laboratory testing was performeddemonstrating that the device conformed to the USP monograph forabsorbable sutures. | |
| Based on the indications for use, technological characteristics, andcomparison to predicate devices, the blue ORTHOCORD suture hasbeen shown to be substantially equivalent to predicate devices under theFederal Food, Drug and Cosmetic Act. |
510(k) Premarket Notification: Special Blue ORTHOCORD suture
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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K043298
Trade/Device Name: Blue Orthocord Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: November 29, 2004 Received: November 30, 2004
Dear Ms. 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 10 mmerce 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 r ou may, attress, and see 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 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 (240) 276-0115. 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. Provoost
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): Ko 43298
Device Names: Blue ORTHOCORD suture
Indications for Use:
Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Prescription Use V (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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and Neurological Devices
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510(k) Premarket Notificatios TO(ki) Number___________________________________________________________________________________________________________________________________
§ 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.