(65 days)
N18331
No
The summary describes a traditional surgical suture and does not mention any AI or ML components or functionalities.
No
The device, Monodek Synthetic Absorbable Surgical Sutures, is used for soft tissue approximation and provides wound support, which is a supportive function rather than a therapeutic one that treats a disease or condition.
No
The device is described as a surgical suture used for tissue approximation, not for diagnosing medical conditions.
No
The device description clearly indicates a physical, sterile, monofilament surgical suture, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Monodek™ Synthetic Absorbable Surgical Sutures are for "soft tissue approximation" and use in "pediatric cardiovascular tissue" and "ophthalmic surgery." This describes a device used within the body for surgical procedures.
- Device Description: The description details a "sterile, monofilament" suture, which is a physical material used to close wounds or hold tissues together.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, analyzers, or test kits used with biological samples like blood, urine, or tissue.
Therefore, the Monodek™ Synthetic Absorbable Surgical Suture is a surgical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Monodek™ Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Product codes
NEW
Device Description
Monodek Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture is a sterile, monofilament and 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
soft tissue, pediatric cardiovascular tissue, opthalmic
Indicated Patient Age Range
pediatric (for cardiovascular tissue)
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.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV - 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", December 19, 2002
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
N18331
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
K0 30 212
MAR 2 7 2003
EXHIBIT A 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 | Genzyme Biosurgery
A Division of Genzyme Corporation
600 Airport Road
Fall River, MA 02720-4740 |
|--------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person | Stephen Page
Phone: (508) 677-6543
Fax: (508) 677-6663
e-mail: Steve.Page@Genzyme.com |
| Date Prepared | March 21, 2003 |
| Device Information | |
| Trade Name: | Monodek™ Synthetic Absorbable Surgical Suture. |
|---|---|
| Common Name: | Polydioxanone Absorbable Surgical Sutures. |
| Classification Name: | Absorbable Polydioxanone Surgical Sutures |
Indications for Use
Monodek™ Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Device Description
Monodek Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture is a sterile, monofilament and 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
EXHIBIT A
510(k) Summary
Substantial Equivalence
The device is similar in intended use, materials, design, and performance characteristics to the currently cleared CP Medical Mono-Dox Absorbable Surgical Sutures (#K013274) and the currently approved Ethicon PDS II Absorbable Surgical Suture (PMA N18331).
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices, USP Section XXV - 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", December 19, 2002
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with a ribbon-like element flowing beneath them.
MAR 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Stephen Page Director of Regulatory Affairs Genzyme Biosurgery 600 Airport Road Fall River, Massachusetts 02720-4740
Re: K030212
Monodek™ Synthetic Absorbable Surgical Suture Regulation Number: 878.4840 Regulation Name: Polydioxanone Suture Regulatory Class: II Product Code: NEW Dated: January 16, 2003 Received: January 21, 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, 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. This letter will allow you to begin marketing your device as described in your Section 510(k)
3
Page 2 - Mr. Stephen Page
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,
Muriam 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
510(k) Number (if known) K0302/2 Device Name
Monodek Polydioxanone Absorbable Surgical Suture
Indications for Use
Monodek™ Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) 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 _ X (Per 21 CFR § 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
Meriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K030212