Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and performance of surgical sutures, with no mention of AI or ML technology.

Therapeutic

No.
The device is described as synthetic absorbable surgical sutures, intended for general soft tissue approximation and/or ligation. This function is for surgical repair and not for treating or curing a disease or condition.

Diagnostic

No

The devices are described as "synthetic absorbable surgical sutures" intended for "general soft tissue approximation and/or ligation." Their use is for surgical repair, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states the devices are "synthetic absorbable surgical sutures" and details their physical composition and form (multifilament, braided, monofilament, with or without needles). This indicates a physical medical device, not a software-only one.

IVD (In Vitro Diagnostic)

Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).

Here's why:

Intended Use: The intended use clearly states that these devices are "indicated for use in general soft tissue approximation and/or ligation." This describes a surgical procedure performed on the body, not a test performed outside the body on a sample.
Device Description: The devices are described as "synthetic absorbable surgical sutures." Sutures are used to close wounds or tie off blood vessels during surgery.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific substances, or providing diagnostic information based on laboratory testing.

IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. These surgical sutures do not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

GLYCOLON® 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.

PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue.

PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.

Product codes (comma separated list FDA assigned to the subject device)

GAM

Device Description

The subject devices are synthetic absorbable surgical sutures.

PGA Resorba: Primary material: Polyglycolic acid (PGA). Material presentation: Multifilament, braided. Dyed or undyed: Undyed and dyed D&C violet No.2. Coated or uncoated: Coated Polycaprolactone + calcium stearate. Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.

PGA resoquick: Primary material: Polyglycolic acid (PGA). Material presentation: Multifilament, braided. Dyed or undyed: Undyed. Coated or uncoated: Coated Polycaprolactone + calcium stearate. Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.

Glycolon: Primary material: Copolymer glycolide and E-caprolactone (PGA/CL). Material presentation: Monofilament. Dyed or undyed: Undyed and dyed D&C violet No.2. Coated or uncoated: Uncoated. Suture material is a sterile, flexible, thread offered in a variety of lengths, reels, range of diameters, with or without needles attached.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

general soft tissue, ophthalmic surgery (PGA RESORBA), ophthalmic (e.g. conjunctiva) (PGA resoquick)

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)

Performance Testing Summary: As per the FDA's Class II Special Control Guidance Document for Surgical Sutures, the devices were subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. Testing included:

Diameter
Tensile strength
Needle attachment

Resorption profiles have been evaluated for each material. Resorption data in-vitro and in-vivo were provided for PGA Resorba, Glycolon and in-vivo only for PGA resoquick.

Results of USP performance and resorption testing demonstrate that each absorbable suture meets the current USP performance requirements for absorbable sutures (with the exception of GLYCOLON® that has minor variations in diameter from USP) and they are substantially equivalent to each corresponding predicate device listed.

Biocompatibility evaluation in accordance with ISO 10993-1 has been supported for each material by leveraging data from each supplier and each material having an established history of use for the same intended use.

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.

K984374, K011372, K062366, K960653

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

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2015

Resorba Medical GmbH % Mr. Karl Beck Quality Assurance/Regulatory Affairs Manager Am Flachmoor 16 90475 Nürnberg Germany

Re: K143584

Trade/Device Name: PGA RESORBA, PGA RESOQUICK, GLYCOLON Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: September 23, 2015 Received: September 28, 2015

Dear Mr. Beck:

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

1

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 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" (21 CFR 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

2

Indications for Use

510(k) Number (if known) unknown

Device Name GLYCOLON Absorbable poly(glycolide/l-lactide) surgical suture

Indications for Use (Describe)

GLYCOLON® 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Indications for Use

510(k) Number (if known) unknown

Device Name

PGA resorba Absorbable poly(glycolide/l-lactide) surgical suture

Indications for Use (Describe)

PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

4

Indications for Use

510(k) Number (if known) unknown

Device Name

PGA resoquick Absorbable poly(glycolide/l-lactide) surgical suture

Indications for Use (Describe)

PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

5

5.0 TRADITIONAL 510(K) SUMMARY

Submitted by: Resorba Medical GmbH Am Flachmoor 16 90475 Nuremberg Germany Tel: +49 9128-9115-0 Fax: +49 9128-9115-10

Karl-Josef Beck/Rose Guang Contact Person:

Date of Summary: 30 October 2015

Trade Name	Common Name	Classification Name	Regulation Classification
PGA
RESORBA®	Suture, absorbable,
synthetic,
polyglycolic acid	Absorbable
poly(glycolide/l-
lactide) surgical
suture	21 CFR
§878.4493	GAM	II	Surgisorb,
Samyang
K984374
PGA
Resoquick™	Suture, absorbable,
synthetic,
polyglycolic acid	Absorbable
poly(glycolide/l-
lactide) surgical
suture	21 CFR
§878.4493	GAM	II	Safil Quick,
Aesculap
K011372
*Surgisorb,
Samyang
K984374
*Optime
Peters
Surgical
K062366
GLYCOLON®	Suture, absorbable,
synthetic,
polyglycolic acid	Absorbable
poly(glycolide/l-
lactide) surgical
suture	21 CFR
§878.4493	GAM	II	Monocryl
Ethicon
K960653

*Secondary predicates

6

The subject devices are synthetic absorbable surgical sutures. Device Description:

	PGA Resorba	PGA resoquick	Glycolon
Primary material	Polyglycolic acid
(PGA)	Polyglycolic acid
(PGA)	Copolymer glycolide
and E-caprolactone
(PGA/CL)
Material presentation	Multifilament,
braided	Multifilament,
braided	Monofilament
Dyed or undyed	Undyed and dyed
D&C violet No.2	Undyed	Undyed and dyed
D&C violet No.2
Coated or uncoated	Coated
Polycaprolactone +
calcium stearate	Coated
Polycaprolactone +
calcium stearate	Uncoated
Suture material is a
sterile, flexible, thread
offered in a variety of
lengths, reels, range of
diameters, with or
without needles
attached.	Yes	Yes	Yes

Indication for Use: PGA RESORBA® is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not in cardiovascular surgery or neural tissue.

PGA resoquick™ is indicated for use in general soft tissue approximation, including ophthalmic (e.g. conjunctiva) procedures, but not in cardiovascular or neurological procedures.

GLYCOLON® 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.

Each absorbable suture has the same intended use and similar design, Substantial Equivalence: materials, labeling, performance characteristics to their predicate device.
y

7

Absorbable sutures	Page 5-3
Traditional 510(k) Premarket Notification

Technological Each absorbable suture is substantially equivalent to the predicate device listed when compared to the technological characteristics and are characteristics supplied sterile for single use. All meet USP requirements except for minor variations in diameter for Glycolon® monofilament absorbable suture.

Comparison of technological characteristics to predicate device:

| | Intended use | Material | Design | Performance
Diameter/
Needle
attachment/
Tensile
strength |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| PGA
RESORBA | Indicated for use in
general soft tissue
approximation and/or
ligation, including use in
ophthalmic surgery, but
not in cardiovascular
surgery or neural tissue | Material:
Polyglycolic acid
(PGA)
Coating:
Polycaprolactone +
calcium stearate

to

8

Performance Testing As per the FDA's Class II Special Control Guidance Document for Surgical Summary: Sutures, the devices were subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. Testing included:

. Diameter
0 Tensile strength
. Needle attachment

Resorption profiles have been evaluated for each material. Resorption data in-vitro and in-vivo were provided for PGA Resorba, Glycolon and in-vivo only for PGA resoquick.

Results of USP performance and resorption testing demonstrate that each absorbable suture meets the current USP performance requirements for absorbable sutures (with the exception of GLYCOLON® that has minor variations in diameter from USP) and they are substantially equivalent to each corresponding predicate device listed.

Biocompatibility evaluation in accordance with ISO 10993-1 has been supported for each material by leveraging data from each supplier and each material having an established history of use for the same intended use.

Based on the information provided within this 510(k) submission, Conclusion Resorba Medical GmbH concludes that the proposed suture products are substantially equivalent to each corresponding predicate device listed.

y