(31 days)
No
The device description and performance studies focus on the physical properties and performance of a surgical suture, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or manages a disease or condition. This device is a suture used for soft tissue approximation and ligation, which is a supportive rather than a therapeutic function.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical suture made of polyglycolic acid, not a software product.
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," which is a surgical procedure performed directly on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
- Device Description: The device is a surgical suture, a physical material used to close wounds or tie off blood vessels. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological samples.
Therefore, the POLYS YN™ Polyglycolic Acid (PGA) Suture is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
POLYSYNTM Polyglycolic Acid (PGA) Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in Cardiovascular and Neurological procedures.
Product codes
GAM
Device Description
PGA Sutures are supplied as braided or monofilament, dyed (violet) or undyed and coated or uncoated. The pigment for the violet is D&C Violet #2. Where applicable, the coating is a copolymer of polycarpolactone and calcium stearate. The PGA Suture is available in Size 2 through Size 10-0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue, ophthalmic
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
Non-clinical laboratory performance testing was conducted to confirm that the PolySynTM suture conforms to the USP monograph for absorbable sutures (as applicable). This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003. Additional performance testing was conducted in order to demonstrate substantial equivalence to the predicate device including in vitro post-hydrolysis tensile testing. The results of this testing demonstrates that the PolySynTM suture is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
JUI. 18 2014
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Page 1 of 2 K141625
510(k) Summary
ﺗﮯ
| Date Prepared: | Jul 17, 2014 |
|---|---|
| Company: | Surgical Specialties Corporation |
| 100 Dennis Dr. | |
| Reading, PA 19606 | |
| Contact: | Paul Amudala |
| Regulatory Affairs Specialist | |
| Phone: 610-404-3376 | |
| Fax: 610-404-3924 | |
| Email: pamudala@surgicalspecialties.com | |
| Device trade name: | PolySynTM (PGA) Surgical Suture |
| Device Common Name: | Absorbable Polyglycolic Acid Surgical Suture |
| Device classification: | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Product code, GAM | |
| 21 CFR 878.4493 | |
| Class II | |
| Legally marketed device | |
| to which the device is | |
| substantially equivalent: | K965162: PolySynTM Surgical Suture (primary) |
| K022269 Coated VICRYLTM (Polyglactin) Suture (reference) | |
| Description of the | |
| device: | PGA Sutures are supplied as braided or monofilament, dyed (violet) or undyed and coated or uncoated. The pigment for the violet is D&C Violet #2. Where applicable, the coating is a copolymer of polycarpolactone and calcium stearate. The PGA Suture is available in Size 2 through Size 10-0. |
| Indications for Use: | PolySynTM (Polyglycolic Acid (PGA)) Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in Cardiovascular and Neurological procedures. |
| Substantial | |
| Equivalence: | The proposed additional diameter sizes, USP Size 7-0 through 10-0, of the PolySynTM suture product line have the same material (K965162), design, intended use and technological characteristics as the predicate device. The only difference between the proposed and predicate (K965162) device is the suture diameter. |
1
| K
4 | 1
4 | 1 | 625 | |
|--------|--------|---|-----|--|
| | | | | |
.
: .
Page 2 of 2
.
| Performance tests: | Non-clinical laboratory performance testing was conducted to
confirm that the PolySyn™ suture conforms to the USP
monograph for absorbable sutures (as applicable). This testing
was performed in accordance with FDA's Class II Special
Controls Guidance Document: Surgical Sutures, Issued June 3,
2003. Additional performance testing was conducted in order to
demonstrate substantial equivalence to the predicate device
including in vitro post-hydrolysis tensile testing. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The results of this testing demonstrates that the PolySyn™ suture
is substantially equivalent to the predicate devices. |
l
.
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drue Administration 10903 New Hampshire Avenue Document Contral Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Surgical Specialties Corporation Mr. Paul Amudala Regulatory Affairs Specialist 100 Dennis Drive Reading, Pennsylvania 19606
Re: K141625
Trade/Device Name: POLYSYN" (Polyglycolic Acid) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: June 18, 2014 Reccived: June 19, 2014
Dear Mr. Amudala:
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 cnactment 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. Ilisting 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 complics 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 - Mr. Paul Amudala
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on fast page.
510(k) Number (if known) K141625
Device Name
POLYS YN™ (Polyglycolic Acid) Surgical Suture
Indications for Use (Describe)
POLYS YN™ Polyglycolic Acid (PGA) Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in Cardiovascular and Neurological procedures.
Type of Use (Select one or both, as applicable)
[ Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Peter L. Hud 2014.07.18 07:27
FORM FDA 3881 (1/14)