Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and biological properties of a surgical suture, with no mention of AI or ML technologies.

Therapeutic

No.
The device is a surgical suture used for approximation and/or ligation of soft tissue, not for providing therapy to a disease or condition.

Diagnostic

No

This device is a surgical suture used for approximation and/or ligation of soft tissue, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical surgical suture made of a specific copolymer, not software.

IVD (In Vitro Diagnostic)

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 a patient's body.
Device Description: The device is a "synthetic monofilament absorbable surgical suture." This is a physical material used to close wounds or tie off blood vessels during surgery.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are designed for this type of testing.

Therefore, this device is a surgical implant/device used in vivo (within the body) during a surgical procedure, not an in vitro diagnostic used for testing specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

DemeCAPRONE (Poliglecaprone 25) Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.
Demetech Absorbable Poliglecaprone 25 Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.

Product codes

GAM

Device Description

DemeCAPRONE (Poliglecaprone 25) is a synthetic monofilament absorbable surgical suture composed of Poly (glycolic-co-caprolactone) copolymer (PGCL) and is supplied un-dyed and dyed with D&C Violet #2 below 0.1wt%. DemeCAPRONE (Poliglecaprone 25) synthetic absorbable suture is available in sizes 6-0 through 1 (metric sizes 0.7 - 4). DemeCAPRONE (Poliglecaprone 25) Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures except for diameter.

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

Not Found

Summary of Performance Studies

Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and invivo and in-vitro resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 35. Poliglecaprone 25 was selected based on known biocompatibility (per ISO 10993) and established history of use in the medical device industry for implantable devices, and are identical or substantially equivalent to the material used in the predicate devices listed above. Biocompatibility testing performed on Poliglecaprone 25 sutures within the submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity - Bacterial Reverse Mutation and Chromosomal Aberration, Bone Marrow Micronucleus, Subchronic Toxicity (4-week, following subcutaneous implantation), Muscle Implantation (12-week).
No clinical trials were conducted.

Key Metrics

Not Found

Predicate Device(s)

K100461, K081002, K960653 & K964072

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

DemeTECH.

JUL 1 7 2013

Section 1 - 510(k) Summary

This summary is submitted in accordance with the Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR § 807.92. This summary demonstrates the equivalence of Demetech Sutures to those of the legally marked devices listed.

| A. Applicant: | Demetech Corporation,
14175 NW 60th Ave.
Miami Lakes FL. 33014 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| B. Contact Person: | A. J. Dimercurio
e-mail: tony@demetech.us
Phone # 305-824-1048 Ext 115 |
| C. Date Prepared: | July 15th, 2013 |
| Trade Name: | DemeCaprone (Poliglecaprone
25) Synthetic Monofilament
(PGCL) Absorbable Suture |
| Common Name: | DemeTECH Synthetic PGCL
Monofilament Poliglecaprone 25
Absorbable Suture |
| Classification Name: | Absorbable poly (glycolide/l-
lactide) Surgical Suture braided
or monofilament |
| D. Device Classification | |
| FDA Class:
Product Classification: | II
878.4493, Absorbable
Poly(glycolide/I-lactide) Surgical
Suture |
| Product Code: | GAM |
| E. Predicate Devices: DemeCAPRONE (Poliglecaprone 25) Synthetic
Absorbable Surgical Suture is substantially equivalent to these predicate
devices: | |
| • Riverpoint's Mono Q PGCL Absorbable Suture reference 510K number
K100461, Riverpoint Medical. Portland OR. | |

Sutures India PVT.LTD Monoglyde Poliglecaprone 25 Absorbable Suture . reference 510K number K081002, Sutures India Private Limited Bangalore India.

. . . . .

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

1

K130083 page 2/5

Ethicon's Monocryl Synthetic Absorbable Poliglecaprone 25 suture, . reference 510K number, K960653 & K964072, Ethicon Inc. Somerville NJ.
F. Device Description:

DemeCAPRONE (Poliglecaprone 25) is a synthetic monofilament absorbable surgical suture composed of Poly (glycolic-co-caprolactone) copolymer (PGCL) and is supplied un-dyed and dyed with D&C Violet #2 below 0.1wt%. DemeCAPRONE (Poliglecaprone 25) synthetic absorbable suture is available in sizes 6-0 through 1 (metric sizes 0.7 - 4). DemeCAPRONE (Poliglecaprone 25) Surgical Suture meets the requirements established by the United States Pharmacopeia (U.S.P.) for synthetic absorbable surgical sutures except for diameter.

G. Intended Use:
DemeCAPRONE (Poliglecaprone 25) Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.
H. Non-Clinical Tests Performed:
Non-clinical testing was conducted on the device per FDA's Special Control Guidance Document: Surgical Sutures, to prove conformance to the requirements of USP for synthetic absorbable suture, biocompatibility testing in accordance to ISO 10993-1 and invivo and in-vitro resorption to further demonstrate substantial equivalence to the predicate devices. Physical properties and functionality testing assured that the device conformed with suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in USP 35.

Poliglecaprone 25 was selected based on known biocompatibility (per ISO 10993) and established history of use in the medical device industry for implantable devices, and are identical or substantially equivalent to the material used in the predicate devices listed above. Biocompatibility testing performed on Poliglecaprone 25 sutures within the submission includes the following: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Genotoxicity - Bacterial Reverse Mutation and Chromosomal Aberration, Bone Marrow Micronucleus, Subchronic Toxicity (4-week, following subcutaneous implantation), Muscle Implantation (12-week).

COMPARISON TABLE DEMETECH POLIGLECAPRONE 25 TO PREDICATE
DEVICES
Comparison Items	Demetech
Poliglecaprone
25 Suture	Riverpoint's
Mono Q
PGCL
Suture	Sutures
India
Monoglyde
Suture	Ethicon
Monocryl
Suture
DemeCAPRONE
(Poliglecaprone 25) suture is a
synthetic absorbable surgical
suture. It is a sterile flexible
monofilament thread, composed
of Poly (glycolic-co-
caprolactone) copolymer	Same	Same	Same	Same
Same	Same	Same	Same



Same	Same	Same	Same





Same	Same	Same	Same





Same	Same	Same	Same



Same	Same	Same	Same


Same	Same	Same	Same





Same	Same	Same	Same







Same	Same	Same	Same





		Same



	Same	Same		Same

DemeCAPRONE meets or
exceeds the performance
requirements defined in the
United States Pharmacopeia for
"Tensile Strength"	Same	Same	Same	Same
DemeCAPRONE meets or
exceeds the performance
requirements defined in the
United States Pharmacopeia and
the current edition USP for
"Needle Attachment"	Same	Same	Same	Same
DemeCAPRONE meets or
exceeds the performance
requirements defined in the
United States Pharmacopeia for
"Suture Length Requirement"
(95% of stated label length)	Same	Same	Same	Same
DemeCAPRONE meets the
performance requirements
defined in the United States
Pharmacopeia current edition
U.S.P. for sterility	Same	Same	Same	Same
DemeCAPRONE is packaged in
a same or equivalent manner
with sterile single or double
packaging having labeling
conforming to 21 CFR and
Current edition of USP.	Same	Same	Same	Same
DemeCAPRONE
(Poliglecaprone 25) suture is
biologically compatible when
tested as per ISO-10993	Same	Same	Same	Same
DemeCAPRONE
(Poliglecaprone 25) suture is
tested and proved to be non
toxic, when tested as per ISO-
10993 for toxicity	Same	Same	Same	Same

2

K130063 page 3/5

3

K130083 page 4/5

Clinical Tests Performed: l.

.

No clinical trials were conducted

4

K130083 page 5/5

J. Conclusion:

DemeCAPRONE (Poliglecaprone 25) is composed of the same material, as are the predicated devices and the same design being a sterile, flexible, monofilament threads meeting all the requirements of the United States Pharmacopeia. DemeCAPRONE (Poliglecaprone 25) Suture is manufactured in the same manner as the predicate devices, being composed of composition of absorbable flexible, monofilament thread prepared from Poly (glycolic-co-caprolactone) copolymer (PGCL) and produced in operations considered standard in the fiber industry to form the finished suture fiber. The manufacturer supplies to Demetech the same suture materials as it does to other suture manufacturers including some of those listed above.

The biocompatibility data and the results of performance testing presented demonstrate the substantial equivalence of DemeCAPRONE (Poliglecaprone 25) Synthetic Absorbable Suture to that of the predicate devices.

5

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 17, 2013

DemeTECH Corporation % Anthony J. Dimercurio Vice President RA/OA 14175 NW 60th Avenue Miami Lakes, Florida 33014

Re: K130083

Trade/Device Name: DemeCaprone (Poligecaprone 25) Synthentic (PGCL) Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM Dated: May 29, 2013 Received: May 31, 2013

Dear Mr. Dimercurio:

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

6

Page 2 - Anthony J. Dimercurio

CFR Part 807): labeling (21 CFR Part 801); medical device reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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,

For

Peter D. Rumm -S Mark N. Melkerson

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

Image /page/7/Picture/0 description: The image shows the logo for DemeTECH. The logo consists of a stylized globe-like symbol on the left, followed by the company name "DemeTECH" in a bold, italicized font. The "CH" portion of the name is slightly smaller and raised, with a small circle as a subscript.

Section 6 - Indications for Use Statement

Indication for use

510K Number: _________________________________________________________________________________________________________________________________________________________________

Device Name: Demetech Absorbable Poliglecaprone 25 Surgical Suture.

Indication for Use:

Demetech Absorbable Poliglecaprone 25 Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use cardiovascular surgery, microsurgery, ophthalmic surgery and neurological tissue.

Prescription Use	"X"
Use
(Part 21 CFR 801; Subpart D)
And/Or
Over the-Counter
(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)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130083