(66 days)
Not Found
No
The summary describes a standard surgical suture and does not mention any AI or ML components or functionalities.
No
This device is a surgical suture used for soft tissue approximation, which falls under general surgical tools rather than a therapeutic device designed for treating a disease or improving health outcomes directly.
No
Explanation: This device is a surgical suture used for tissue approximation, which is a treatment, not a diagnostic function.
No
The device description clearly describes a physical surgical suture made of polyblend material, 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 is "General soft tissue approximation including use in cardiovascular, ophthalmic and neurological procedures." This describes a surgical device used in vivo (within the body) to physically join tissues.
- Device Description: The description details a "surgical suture" made of specific materials and sterilized for surgical use. This aligns with a surgical implant or device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
In summary, the device is a surgical suture, which is a medical device used during surgery, not an in vitro diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
General soft tissue approximation including use in cardiovascular, ophthalmic, and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT
Device Description
The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures.
CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.
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)
Not Found
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.
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.
Not Found
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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
Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the CP Medical absorbable seeding spacer product.
| Manufacturer: | CP Medical, Inc.
803 NE 25th Avenue
Portland, OR 97232
PHONE: (503) 232-1555
FAX: (503) 230-9993 |
|-----------------|--------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Ann Greenawalt, VP
Legal & Regulatory Affairs |
| Device Name: | |
| Trade Name: | Polyblend surgical suture |
|---|---|
| Common Name: | Nonabsorbable polyblend surgical suture |
| Proprietary name: | CP Fiber |
| Classification: | Class II; GAT |
July 8, 2004 Date Prepared:
Predicate Device: The predicate device to the proposed CP Medical polyblend surgical suture, CP Fiber, is the existing CP Medical polyester surgical suture device. K001172 and Arthrex's FiberWIRE™ polyblend suture K010673, K021434.
Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbable sutures, may be siliconecoated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The sutures may also be provided with or without a standard needle attached.
Device Description:
The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures.
CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.
Indications for Use:
General soft tissue approximation including use in cardiovascular, ophthalmic, and neurological procedures. end
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a seal or logo featuring a stylized bird design. The bird is composed of three curved lines that suggest wings and a body. The seal is circular, with text arranged around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The overall design is simple and symbolic, likely representing a government agency related to health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2004
Ms. Mary Ann Greenawalt Vice President Legal & Regulatory CP Medical 803 NE 25th Avenue Portland, Oregon 97232
Re: K041894
Ro41071
Trade/Device Name: CP Fiber, Non-Absorbable Polyblend Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable PET surgical suture Regulatory Class: II Product Code: GAT Dated: August 10, 2004 Received: August 18, 2004
Dear Ms. Greenwalt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your betermined 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 encreas, 1976, the enactment date of the Medical Device Amendments, or to conniner of the to they 2011 - 11:25 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costiere Free (110.) that the device, subject to the general controls provisions of the Act. The r ou may, merelove, manes of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is onastice (porace royals. Existing major regulations affecting your device can Inay be subject to satil additions, 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 I heast of advised that I Dr Pression that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must of ally it cacial statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It rail 607), idoening (21 CFR Part 820); and if applicable, the electronic form in the quarty byetenis (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Ms. Mary Ann Greenawalt
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 manieting your antial equivalence of your device to a legally premarket notheation: "The PDF intellig of easification 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 ac 110 % 4659. Also, please note the regulation entitled, and Contact the Office of Complanes as (So t notification" (21CFR Part 807.97). You may obtain Misolanding of Terefore to premation on your responsibilities under the Act from the Division of Small other gelleral information on your responses at its toll-free number (800) 638-2041 or Manufacturers, Internet and Goless 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
3
Page 1_ of __ 1
510(k) Number (if known): K041894
CP Fiber, Non-Absorbable Polyblend Surgical Suture Device Name:
Indications for Use:
General soft tissue approximation including use in cardiovascular, ophthalmic and neurological procedures.
Please do not write below this line - continue on another page if necessary
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041894
Prescription Use
or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(per 21 CFR 801.109)