(48 days)
Not Found
No
The 510(k) summary describes a surgical suture and its physical properties and intended use. There is no mention of AI or ML in the device description, intended use, or performance studies. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is a surgical suture used for tissue approximation and ligation, which is a supportive role in healing rather than directly treating a disease or condition to restore health.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions. Its purpose is to repair and support tissues, which is a treatment function, not a diagnostic one.
No
The device description clearly indicates it is a physical surgical suture made of Poly (L-lactide), a braided multifilament, and is supplied with or without needles. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical suture used for approximating and ligating soft tissue and for orthopedic repairs. This is a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details a surgical suture made of Poly (L-lactide). This is a physical implantable material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo to physically repair tissue.
N/A
Intended Use / Indications for Use
Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.
Product codes
GAM
Device Description
Orthodek Poly (L-lactide) Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Orthodek is available in size 2 (metric size 5) undyed (white). The suture is a sterile, braided multifilament, is provided in a variety of lengths, with or without needles, and may be supplied in a variety of cut lengths or on ligating reels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, tendon, ligament, bone
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, performance testing and conformance with voluntary performance standards, e.q. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXVI -Absorbable Surgical Sutures, Guidance Document "Guidance for Surgical Suture 510(k) s" issued on August 10, 2000 and the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA", June 3, 2003.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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
K033/15
p/2
NOV 17 2003
SECTION VI
510(k) Summary
Substantial Equivalence
In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Manufacturer | Teleflex Medical
600 Airport Road
Fall River, MA 02720-4740 |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact Person | Stephen Page
Phone: (508) 677-6543
Fax: (508) 677-6663
E-mail: spage@teleflexmedical.com |
| Date Prepared | October 27, 2003 |
| Device Information | |
| Trade Name: | Orthodek™ Poly(L-lactide) Synthetic
Absorbable Surgical Suture. |
| Common Name: | Poly (L-lactide) Synthetic Absorbable Surgical
Sutures. |
| Classification Name: | Absorbable Poly (glycolide/L-lactide) Surgical
Suture. |
Indications for Use
Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.
Device Description
Orthodek Poly (L-lactide) Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Orthodek is available in size 2 (metric size 5) undyed (white). The suture is a sterile, braided multifilament, is provided in a variety of lengths, with or without needles, and may be supplied in a variety of cut lengths or on ligating reels.
1
K033/15 P2/2
SECTION VI 510(k) Summary (Cont.)
Substantial Equivalence
The device is similar in intended use, materials, design, and performance characteristics to the cleared Ethicon Panacryl Absorbable Surgical Suture (K974299). Minor differences between the Teleflex Medical Suture and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function or intended use of this device.
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.q. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXVI -Absorbable Surgical Sutures, Guidance Document "Guidance for Surgical Suture 510(k) s" issued on August 10, 2000 and the FDA "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA", June 3, 2003.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with a stylized design resembling a bird or flowing fabric above them.
Public Health Service
NOV 1 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Page Director, Regulatory Affairs Teleflex Medical 600 Airport Road Fall River, Massachusetts 02720
Re: K033115 Trade/Device Name: Orthodeck™ Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: September 22, 2003 Received: September 30, 2003
Dear Mr. Page:
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. Iisting 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 - Mr. Stephen Page
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 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. 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
4
Image /page/4/Picture/0 description: The image contains handwritten text that appears to be a combination of letters and numbers. The text reads 'K033/15'. The characters are written in a simple, slightly slanted style, and the overall impression is that of a quick note or label.
510(k) Number (if known) Device Name
Orthodek Poly(L-lactide) Absorbable Surgical Suture
Indications for Use
Orthodek™ Synthetic Absorbable Surgical Suture is indicated for use in general soft tissue approximation and /or ligation, and orthopedic uses including tendon and ligament repairs and reattachment to bone but not for use in ophthalmic, cardiovascular or neurological tissue. Orthodek suture is particularly useful where extended wound support (up to 6 months) is desirable.
· (Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
Over-the-Counter Use __
(Optional Format 1-2-96)
Miriam C. Provost
Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number: K033115