(10 days)
K040004, N18331
K040004, N18331
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used for tissue approximation and ligation, which is a tool used during treatment, not a therapeutic device in itself designed to treat a disease or condition.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device is a physical suture, not a software application. The description details its material composition and intended use in surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Blue ORTHOCORD suture is a surgical suture used for "general soft tissue approximation and/or ligation, including use in orthopedic surgeries." This is a device used within the body during a surgical procedure, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or analytes.
- Providing diagnostic information based on laboratory testing.
Therefore, based on the provided information, the Blue ORTHOCORD suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Blue ORTHOCORD suture is indicated for use in general soft tissue approximation and/or ligation, including use in orthopedic surgeries.
Product codes
NEW, GAT
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K040004, N18331
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 0 2004
:
510(k) SUMMARY
Blue ORTHOCORD suture
| Submitter's Name and
Address: | DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062 | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt
Project Management Lead, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-3188
Facsimile: 781-278-9578
e-mail: rcforstad@ethus.jnj.com | |
| Name of Medical Device | Classification Name:
Common/Usual Name:
Proprietary Name: | Non-absorbable poly(ethylene terephthalate)
surgical suture; and
Suture, Surgical, Absorbable, Polydioxanone
Suture
Blue ORTHOCORD suture |
| Substantial Equivalence | Blue ORTHOCORD suture is substantially equivalent to:
Violet ORTHOCORD suture (K040004) manufactured by Mitek; and
PDS 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 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. | |
| Device Description | 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. | |
| Indications for Use | Blue ORTHOCORD suture is indicated for use in general soft tissue
approximation and/or ligation, including use in orthopedic surgeries. | |
| Safety and Performance | 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 blue 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 Blue ORTHOCORD suture
1
! :
2
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.
3
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
4
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
Page 1 of
and Neurological Devices
Page 1 of __
510(k) Premarket Notificatios TO(ki) Number___________________________________________________________________________________________________________________________________