(89 days)
No
The device description and intended use are for a surgical suture, and there is no mention of AI or ML in the provided text. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a suture, indicated for soft tissue approximation and ligation, which is a structural or mechanical function rather than a therapeutic one (e.g., preventing, treating, or diagnosing a disease or condition therapeutically).
No
Explanation: The device is a suture, indicated for soft tissue approximation and ligation, which is a therapeutic rather than a diagnostic function.
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 for "general soft tissue approximation, and/or ligation, including orthopaedic procedures." This describes a surgical device used directly on a patient's body for structural support and repair.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVDs are devices used in vitro (in glass, or outside the body) to analyze biological samples. This device is clearly used in vivo (in the body) during surgical procedures.
N/A
Intended Use / Indications for Use
ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.
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 Violet #2 or 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
Not Found
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, except for oversized diameter. The proposed Small Size Orthocord sutures are comprised of the same materials and are similar design to the predicate Size 2 Orthocord suture (K040004/K043298) with differences in size and braid construction. The proposed device, Small Size Orthocord, is currently offered in an anchor configuration of the DePuy Mitek's Minilok (K071257) and Microfix (K080352) anchors.
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, K071257, K080352, K946173, K022715, K122374
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.
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
K123668 page 1/2
SECTION 2 - 510(k) SUMMARY
Small Size Orthocord® Suture
FEB 2 6 2013
| Submitter's
Name and
Address | DePuy Mitek
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Tatyana Korsunsky
Regulatory Affairs Specialist
DePuy Mitek, Inc.
a Johnson & Johnson company
325 Paramount Drive
Raynham, MA 02767, USA |
| | Telephone: 508-828-3122
Facsimile: 508-977-6911
e-mail: tkorsuns@its.jnj.com |
| Name of
Medical Device | Proprietary Name: ORTHOCORD®
Classification Name: Suture, surgical, absorbable, polydioxanone;
Suture, nonabsorbable, synthetic, polyethylene
Common Name:
Suture |
| Substantial
Equivalence
Facility | The Small Size Orthocord® Suture is substantially equivalent to:
• K040004: Orthocord® Suture (USP Size 2, Violet) (April 13, 2004)
• K043298: Orthocord® Suture (USP Size 2, Blue) (Dec 10, 2004)
• K071257: Minilok Anchor with #2-0 Orthocord® Suture (Jun 29, 2007)
• K080352: Microfix Anchor with #3-0 and 4-0 Orthocord® Suture (Mar 12, 2008)
• K946173: Ethibond Suture (January 09, 1995)
• K022715: Vicryl Suture (December 19, 2002)
• K122374, K071622, K041553: Fiberwire FiberLoop Suture (September 25, 2012;
July 03, 2007; December 10, 2004) |
| Device
Classification | Class II:
• Sec. 878.4840 Absorbable polydioxanone surgical suture, product code NEW;
• Sec. 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture,
product code GAT. |
| Device
Description | Orthocord® Suture is a synthetic, sterile, braided, composite suture composed of dyed
(D&C Violet #2 or 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 | ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or
ligation, including orthopaedic procedures. |
| 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, except for oversized diameter.
The proposed Small Size Orthocord sutures are comprised of the same materials and
are similar design to the predicate Size 2 Orthocord suture (K040004/K043298) with
differences in size and braid construction. The proposed device, Small Size Orthocord,
is currently offered in an anchor configuration of the DePuy Mitek's Minilok
(K071257) and Microfix (K080352) anchors.
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. |
.
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K123668 page 2/2
Small Size Orthocord Suture Sizes and Configurations: Size 0 Orthocord Suture; (single armed) Size 2-0 Orthocord Suture; (single armed) Size 3-0 Orthocord Suture; (single armed) Size 4-0 Orthocord Suture; (single armed) Size 4-0 Orthocord Suture in a Loop (both ends of suture swaged to one needle)
.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DePuy Mitek Incorporated., A Johnson and Johnson Company % Ms. Tatyana Korsunsky Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts, 02767
Letter dated: February 26, 2013
Re: K123668
Trade/Device Name: Small Size ORTHOCORD® Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW, GAT Dated: January 24, 2013 Received: January 28, 2013
Dear Ms. Korsunsky:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Tatyana Korsunsky
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N.Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123668 Device Name: Small Size ORTHOCORD® Suture Indications for Use:
The Small Size ORTHOCORD® Suture is indicated for:
ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
.
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
David Kraúse
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123668 :
.
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