(47 days)
Not Found
No
The summary describes a surgical suture and does not mention any AI or ML components or functionalities.
Yes
The device, a Modified USS Polypropylene Suture, is indicated for "general soft tissue approximation and/or ligation," which is a therapeutic intervention aimed at repairing or aiding the healing of tissue. This falls under the definition of a therapeutic device designed to treat or alleviate a condition.
No
The device description and intended use indicate that it is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Modified USS Polypropylene Suture," which is a physical medical device (suture material) and 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 states "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The description focuses on the material composition and biocompatibility for direct patient contact. This aligns with a surgical device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Modified USS Polypropylene Suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Product codes
GAW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, cardiovascular, ophthalmic, and neurological
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 performance of the Modified USS Polypropylene Suture is substantially equivalent to the currently marketed USS Polypropylene Suture, which has been successfully used in clinical applications as a wound closure device.
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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.
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| SUBMITTER: | United States Surgical,
a division of Tyco Healthcare Group LP
150 Glover Avenue
Norwalk, CT 06856 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Sharon L. Murphy |
| DATE PREPARED: | April 14, 2005 |
| CLASSIFICATION NAME: | Nonabsorbable Polypropylene Surgical Suture |
| COMMON NAME: | Modified USS Polypropylene Suture |
| PROPRIETARY NAME: | To be determined |
| PREDICATE DEVICES: | USSC Polypropylene Suture (K954808)
Modified USS Polypropylene Suture (K010909) |
| INTENDED USE: | Modified USS polypropylene sutures are indicated for
use in general soft tissue approximation and/or ligation,
including use in cardiovascular, ophthalmic, and
neurological surgery. |
| MATERIALS: | Like all the devices manufactured by United States
Surgical, a division of Tyco Healthcare Group LP, the
Modified USS Polypropylene Suture is composed
entirely of biocompatible materials which are in
compliance with ISO 10993-1 for their intended patient
contact profile. |
| PERFORMANCE: | The performance of the Modified USS Polypropylene
Suture is substantially equivalent to the currently
marketed USS Polypropylene Suture, which has been
successfully used in clinical applications as a wound
closure device. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's emblem in the center, which consists of a stylized human figure with three heads in profile. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 - 2005
Ms. Sharon L. Murphy Director, Regulatory Affairs United States Surgical, 150 Glover Avenue Norwalk, Connecticut 06856
Re: K050947
Trade/Device Name: Modified USS Polypropylene Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: May 3, 2005 Received: May 4, 2005
Dear Ms. Murphy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to tegains and the Medical Device Amendments, or to commence prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvine of the general controls provisions of the Act. The 1 ou may, merclore, market the Act include requirements for annual registration, listing of general controls provisions of viactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (660 across. Existing major regulations affecting your device it may be subject to Saon additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Over ments concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri bristian that your device complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I cuttar statutes and regainents, 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneering your mance of your device to a legally premarket notification. "The I DTP Intering circusion 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 If you desire specific advice for your aconcerner . Also, please note the regulation entitled, contact the Office of Compunation at (216) = 16 = 21 = 3 Part 807.97). You may obtain Milsoranuing by reference to promanton in the Act from the Division of Small other general information on your response at its toll-free number (800) 638-2041 or Manufacturers, internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use V.
K050947 510(k) Number (if known):
Device Name:
Modified USS Polypropylene Suture
Indications For Use:
Modified USS polypropylene sutures are indicated for use in general soft tissue Mounted OBS porypropyrent sincluding use in cardiovascular, ophthalmic, and neurological surgery.
-------------- OR Over-The-Counter Use:____ × Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Restorative
Surgical Devices
Ko 5094