Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Description

MonodermTM suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-caprolactone.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monoderm™ Synthetic Absorbable Surgical Suture:

This 510(k) summary describes a surgical suture, which is a medical device. The regulatory pathway for such devices often relies on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness through extensive human studies. Therefore, the information provided focuses on material properties and performance characteristics, aligning with physical and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance	Comments
Physical Testing (USP 27 Standards)		To ensure the suture meets established quality and performance standards for surgical materials.
Suture Diameter <861>	Performed	Device demonstrated conformance.
Suture Needle Attachment <871>	Performed	Device demonstrated conformance.
Tensile Strength <881>	Performed	Device demonstrated conformance.
Biocompatibility (ISO 10993 Standards)	Performed	To ensure the material is safe for implantation in the human body.
Implant Studies (ISO 10993 Standards)	Performed	To demonstrate rates of tensile strength retention and mass loss, which are crucial for absorbable sutures.
Absorption Time	Dissolves essentially in 91 days	This is a key performance characteristic for absorbable sutures, indicating how long the material provides support before being absorbed by the body. Compared favorably to predicate device.
Material Composition	Copolymer of glycolide and e-caprolactone	This defines the fundamental nature of the device. Confirmed to be similar to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Physical testing was performed on Monoderm™ Synthetic, Absorbable sutures" and "Animal testing was performed," but does not specify the number of sutures or animals used for these tests.
Data Provenance: The document implies prospective testing conducted by the manufacturer, Surgical Specialties Corporation. The origin of the data is internal to the company (Reading, PA, USA) and refers to standardized testing methods (USP, ISO). No country of origin for specific human patient data is mentioned as such studies are not described for this type of device submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This type of information is not applicable to this submission. For physical and material performance testing like those described (suture diameter, tensile strength, biocompatibility, absorption rates), "ground truth" is established through standardized laboratory measurements and scientific protocols, not expert consensus on interpretations of imagery or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" involves physical and animal testing, there is no need for expert adjudication in the way it would be applied to, for example, diagnostic image interpretation. Results are generated through objective measurements and adhere to specified test methods (USP, ISO).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This type of study assesses human reader performance with or without AI assistance, which is irrelevant for a surgical suture and its 510(k) submission based on manufacturing and material performance data.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is a physical surgical suture, not an algorithm or AI-based diagnostic tool. Therefore, "standalone performance" in the context of an algorithm does not apply.

7. Type of Ground Truth Used

The "ground truth" for the performance criteria described is established through:
- Standardized Laboratory Measurements: For physical properties like suture diameter, tensile strength, and needle attachment, the ground truth is the numerical value obtained from calibrated instruments following USP protocols.
- Animal Studies/Biological Assays: For biocompatibility and absorption rates (tensile strength and mass loss over time), the ground truth is derived from the biological responses observed in in vivo animal models and in vitro assays according to ISO 10993 standards.

8. Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm that requires a "training set" in the machine learning sense. The device is a manufactured product whose performance is evaluated against established physical and biological standards.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI training set, there is no ground truth to be established for it. The ground truth for the device's performance relates to its compliance with USP and ISO standards, as outlined in item 7.

Summary

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY

SubmitterAddress:	Surgical Specialties Corporation100 Dennis DriveReading, PA 19606
Telephone:Contact Person:	610 404 1000, ext. 2231Elizabeth LazaroRegulatory Affairs Specialist
Common /Classification Name:	Surgical SutureAbsorbable, Synthetic
Name of Device:	Modified MonodermTM Monofilament,Synthetic Absorbable, Dyedand/or Undyed sutures.
Indications for Use:	Indicated for use in general soft tissue approximation and/or ligation, butnot for use in cardiovascular or neurological tissues, microsurgery orophthalmic surgery.
Predicate Devices	Ethicon's Monocryl(Poliglecaprone 25) E caprolactone/Glycolide510 (k) K930772
	Surgical Specialties Corporation's (Polyglytone 72) Glycolide, and e-caprolactone.510 (k) K040477
Device Description:	MonodermTM suture is a monofilament synthetic absorbable surgicalsuture prepared from a copolymer of glycolide and e-caprolactone.
Performance Data:	Physical testing was performed on MonodermTM Synthetic, Absorbablesutures to USP 27, including <861>Suture Diameter, <871>SutureNeedle Attachment,<881> Tensile Strength. Animal testing wasperformed for conformance to ISO 10993 for biocompatibility andimplant studies to demonstrate rates of tensile strength and mass loss.

Modified Monoderm™ Synthetic, Monofilame nt Absorbable Sutures Surgical Specialties Corporation

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052437

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Technological Characteristics

Surgical Specialties Corporation's Monoderm™Synthetic, absorbable suture is made from a mixture of Glycolide/e-caprolactone. The material has been well characterized through absorption studies and biocompatibility studies. The product is similar to the predicate devices, Monoderm (Polyglactone 72) and Monocryl in that they are both made from a polymer blend of synthetic absorbable materials.

Equivalency:

Absorbable, Synthetic, Monofilament

Surgical Specialties Corporation's Monoderm sutures are made of a synthetic absorbable suture material, which will dissolve essentially in 91 days.

Ethicon`s

Monocryl sutures are made of synthetic absorbable suture material which will dissolve essentially between 91 and 119 days.

Modified Monoderm™ Synthetic Monofilament Absorbable Sutures Surgical Specialties Corporation

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three parallel lines representing health, services, and people. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2005

Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606

Re: K052437

Trade/Device Name: Monoderm™ Synthetic Absorbable Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: September 2, 2005 Received: September 6, 2005

Dear Ms. Lazaro:

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.

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Page 2- Elizabeth Lazaro

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 maneting your maneting of your device to a legally premarket notification. THC PDF mising of cation 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 acon 1000) 276-0115. Also, please note the regulation entitled, Colliact the Oritec of Compliance an (21 t retification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Barbara Buehrig

Mark N. Melkerson 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

K052437 510(k) Number (if known):

Device Name: Monoderm™ Synthetic Absorbable Surgical Suture

Indications for Use:

Monoderm™sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubaie Mullins for Nixon

Division of General, Restorative, and Neurological Devices

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(k) Number K052437

510(k) Number

Regulation Number and Section

§ 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.