(29 days)
Not Found
No
The document describes a surgical suture and its material composition and performance testing, with no mention of AI or ML.
No.
The device is a surgical suture used for approximation and/or ligation of soft tissue, which is a structural or supportive function rather than a therapeutic one as it does not treat or cure a disease.
No
Explanation: The device is a surgical suture, which is used for approximation and/or ligation of soft tissues. Its intended use does not involve diagnosing medical conditions, but rather performing a surgical function.
No
The device description clearly states it is a monofilament synthetic absorbable surgical suture, which is a physical medical 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 is for "general soft tissue approximation and/or ligation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "monofilament synthetic absorbable surgical suture." This is a physical material used to close wounds or tie off blood vessels during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of this suture does not involve any such testing or analysis of biological samples.
Therefore, the MONODERM™ (PGA-PCL) suture is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Product codes
GAM
Device Description
Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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
Non-clinical laboratory performance testing was conducted to confirm that the Monoderm™ (PGA-PCL) 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.
Summary of Performance Studies
Non-clinical laboratory performance testing was conducted to confirm that the Monoderm™ (PGA-PCL) 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 Monoderm™ (PGA-PCL) suture is substantially equivalent to the predicate device.
Key Metrics
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.
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510(k) Summary
ﺔ
ﻠﻰ
| Date Prepared: | February 26, 2014 |
|---|---|
| Company: | Surgical Specialties Corporation |
| 100 Dennis Dr. | |
| Reading, PA 19606 | |
| Contact: | Kirsten Stowell |
| Regulatory Affairs Manager | |
| Phone: 610-404-3367 | |
| Fax: 610-404-3924 | |
| Email: kstowell@angio.com | |
| Device trade name: | Monoderm™ (PGA-PCL) Surgical Suture |
| Device Common Name: | Absorbable Poly(glycolide/l-lactide) 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: | K052437: Monoderm™ (PGA-PCL) Surgical Suture |
| Description of the | |
| device: | Monoderm™ (PGA-PCL) suture is a monofilament synthetic |
| absorbable surgical suture prepared from a copolymer of | |
| glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) | |
| suture is available dyed and undyed in Size 1 through Size 6-0. | |
| Indications for Use: | Monoderm™ (PGA-PCL) suture is indicated for use in general |
| soft tissue approximation and/or ligation, but not for use in | |
| cardiovascular or neurological tissues, microsurgery or | |
| ophthalmic surgery. | |
| Substantial | |
| Equivalence: | The proposed additional diameter sizes, USP Size 1 and 0, of the |
| Monoderm™ (PGA-PCL) suture product line have the same | |
| material, design, intended use and technological characteristics as | |
| the predicate device. The only difference between the proposed | |
| and predicate device is the suture diameter. |
.
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K140227 Page 2/2
Non-clinical laboratory performance testing was conducted to Performance tests: confirm that the Monoderm™ (PGA-PCL) 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.
ﻟﻤ
The results of this testing demonstrates that the Monoderm™ (PGA-PCL) suture is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Surgical Specialties Corporation Ms. Kirsten Stowell Regulatory Affairs Manager 100 Dennis Drive Reading, Pennsylvania 19606
Re: K140227
Trade/Device Name: MONODERM™ (PGA-PCL) 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: January 28, 2014 Received: January 30, 2014
Dear Ms. Stowell:
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. 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 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Kirsten Stowell
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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. Acting 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 last page.
510(k) Number (if known)
Device Name
MONODERM™ (PGA-PCL) Surgical Suture
Indications for Use (Describe)
MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
[] 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)
David Krause -S
FORM நூற்றி திரிப்பு (140) Jure Special 510(k)
5
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