(22 days)
Not Found
No
The description focuses solely on the material composition and intended use of a surgical suture, with no mention of AI or ML capabilities.
No.
The device is a surgical suture used for tissue approximation and ligation, which are mechanical functions rather than therapeutic interventions.
No
Explanation: The device is described as a surgical suture used for soft tissue approximation and/or ligation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical suture made of synthetic materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "general soft tissue approximation and/or ligation, including use in orthopedic surgeries." This describes a surgical device used in vivo (within the body) to physically join or tie tissues.
- Device Description: The description details a surgical suture, a physical material used for stitching.
- Lack of IVD Characteristics: IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information about a patient's health status. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Orthocord #2-0 suture is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Orthocord #2-0 suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
NEW, GAT
Device Description
ORTHOCORD suture is a synthetic, sterile, braided composite suture composed of dyed (D&C Blue #6 or 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP monograph for absorbable sutures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K040004, K043298, K071622, K021434
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K080918 page 1/2
510(k) SUMMARY
APR 2 3 2008
Orthocord #2-0 suture with or without needles Submitter's Name and DePuy Mitek a Johnson & Johnson company Address: 325 Paramount Drive Raynham, MA 02767 Contact Person Kristine Christo Regulatory Affairs Project Lead DePuy Mitek a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767 Telephone: 508 828-3359 508-977-6955 Facsimile: e-mail. KChristo@Dpyus.jnj.com Classification Name: Non-absorbable poly(ethylene terephthalate) Name of Medical Device surgical suture; and Suture, Surgical, Absorbable, Polydioxanone Common/Usual Name: Suture Orthocord suture Proprietary Name: Orthocord #2-0 suture is substantially equivalent to: Substantial Equivalence Orthocord #2 suture (K040004, K043298) manufactured by Mitek; Mini OA+ / Minilok QA+ (K071622) manufactured by Mitek and Fiberwire (K021434) manufactured by Arthrex Sutures, classified by the FDA, are Class II Medical Devices. Device Classification PDS Suture carries an FDA product code NEW, and is classified as absorbable surgical suture, polydiaxanone under 21 CFR 878.4840. Polyethylene suture carries an FDA product code GAT, and is classified under 21 CFR 878.5000. ORTHOCORD suture is a synthetic, sterile, braided composite suture Device Description composed of dyed (D&C Blue #6 or 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.
510(k) Premarket Notification: Special ORTHOCORD #2-0 suture with or without needles
Confidential
1
KOBO918 Page 2/2
Indications for Use
Safety and Performance
ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
The determination of substantial equivalence for this device was based 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 ORTHOCORD suture has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
510(k) Premarket Notification: Special ORTHOCORD #2-0 suture with or without needles
Confidential
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Depuy Mitek % Ms. Kristine Christo Regulatory Affairs Project Lead 325 Paramount Drive Raynham, Massachusetts 02767
APR 2 3 2008
Re: K080918
Trade/Device Name: Orthocord #2-0 suture with or without needles Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW, GAT Dated: March 13, 2008 Received: April 1, 2008
Dear Ms. Christo:
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 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.
3
Page 2 -- Ms. Kristine Christo
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known): K080918
Device Names: Orthocord #2-0 suture with or without needles
Indications for Use:
. . . . .
Orthocord #2-0 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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
| 510(k) Number | K080918 |
|---|---|
| --------------- | --------- |
510(k) Premarket Notification
ORTHOCORD #2-0 suture
with or without needles
Confidential