Caprolon

K181320 · Resorba Medical GmbH · GAM · Sep 18, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K181320
• Device Name: Caprolon
• Applicant: Resorba Medical GmbH
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Sep 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAPROLON® 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

Device Story

CAPROLON® is a synthetic, absorbable, monofilament surgical suture. Composed of Poly(L-lactide-co-ε-caprolactone) (P(LA/CL)), it is available in undyed or dyed (D&C violet No.2) variants. The suture is coated with a mixture of calcium stearate and the copolymer of L-lactide and ε-caprolactone. It is provided sterile in various lengths (35cm to 90cm), diameters (USP 7-0 to 2), and with or without attached needles. Used by surgeons in clinical settings for soft tissue approximation and ligation. The device provides mechanical support to tissues during the healing process and is absorbed by the body over time. Sterilized via ethylene oxide.

Clinical Evidence

Bench testing only. Device evaluated against USP monographs for synthetic absorbable sutures, including diameter <861>, tensile strength <881>, and needle attachment <871>. Resorption profile assessed via in-vitro and in-vivo testing and literature. Biocompatibility testing performed per ISO 10993-1. Stability testing completed.

Technological Characteristics

Material: Poly(L-lactide-co-ε-caprolactone) (P(LA/CL)). Coating: Calcium stearate and L-lactide/ε-caprolactone copolymer. Form: Monofilament, dyed/undyed. USP sizes 7-0 to 2. Sterilization: Ethylene oxide. Meets USP performance requirements for absorbable sutures.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for cardiovascular and neurological procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Monograms Gramsmed (K010672)

Reference Devices

• PDS II Ethicon (N18331)

Submission Summary (Full Text)

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September 18, 2018

Resorba Medical GmbH c/o Ms. Helen Topping Regulatory Affairs Manager Am Flachmoor 16 90475 Nürnberg Germany

Re: K181320

Trade/Device Name: CAPROLON® Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: July 18, 2018 Received: July 23, 2018

Dear Ms. Topping:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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

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# Indications for Use

510(k) Number (if known) K181320

# Device Name

CAPROLON Absorbable poly(glycolide/l-lactide) surgical suture

Indications for Use (Describe)

CAPROLON® 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) |
|-------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">☑</span> Reproduction Use (Part 31 CFR 901 Subpart D) |
| ☐ Consumptive Use (31 CFR 901 Subpart C) |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the Resorba company logo, which includes the company name in bold letters, along with the tagline "REPAIR AND REGENERATE". Below the logo, it states that Resorba is "an Advanced Medical Solutions Group plc company". In the upper right corner, there is a document identifier "K181320" and page number "p. 1 of 4".

Fon +49 (0) 9128/9115 0 Fax [phone]

RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberg

export @ resorba.com www.resorba.com

# 510(k) Summary Statement

| Submitted by: | Resorba Medical GmbH<br>Am Flachmoor 16<br>90475 Nuremberg<br>Germany<br>Tel: [phone]<br>Fax: [phone] |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>Date of Summary: | Helen Topping<br>16th May 2018 |
| Trade Name | CAPROLON® |
| Common Name | Suture, absorbable, synthetic, polyglycolic acid |
| Classification<br>Name | Absorbable poly(glycolide/l-lactide) surgical suture |
| Regulation<br>Classification | 21 CFR §878.4493 |
| Product Code | GAM |
| Class of device | II |
| Predicate device | Monograms Gramsmed K010672 |
| Reference<br>Predicate | PDS II Ethicon N18331 |

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Image /page/4/Picture/0 description: The image shows the Resorba logo, which includes an orange square with a white wave-like design on the left and the word "RESORBA" in black bold letters on the right. Below the logo, the words "REPAIR AND REGENERATE" are printed in a smaller font. The text "an Advanced Medical Solutions Group plc company" is located below the logo. The text "K181320 p. 2 of 4" is located in the upper right corner of the image.

Fon +49 (0) 9128/9115 0 Fax [phone]

RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberg

export @ resorba.com www.resorba.com

| Device<br>Description: | CAPROLON® is a synthetic absorbable surgical suture.<br>Primary material is Poly(L-lactide-co-ε-caprolactone), P(LA/CL) Material presentation is Monofilament Undyed and dyed (D&C violet No.2) variants Coated with a mixture of calcium stearate and the copolymer of L-lactide and ε-caprolactone Suture material is a sterile, flexible, thread offered in a variety of lengths (35cm to 90cm), reels, range of diameters (USP 7-0 to 2), with or without needles attached. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | CAPROLON® is Indicated for use in general soft tissue approximation and/or<br>ligation, including use in ophthalmic procedures, but not for use in<br>cardiovascular and neurological procedures. |
| Substantial<br>Equivalence: | CAPROLON® has the same intended use and similar design, materials, labeling<br>performance characteristics to its predicate device |
| Technological<br>characteristics | CAPROLON® is substantially equivalent to the predicate device listed when<br>compared to the technological characteristics of primary material, material<br>presentation, dye, coating and are supplied sterile for single use. All meet USP<br>requirements except for variations in diameter. The subject and predicate<br>sutures are manufactured from the identical material from the same material<br>supplier. |

Comparison of technological characteristics to predicate device:

| Characteristic | CAPROLON® | Monograms<br>K010672 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended Use | Indicated for use in general soft<br>tissue approximation and/or<br>ligation, including use in<br>ophthalmic procedures, but not<br>for use in cardiovascular and<br>neurological procedures | Same |
| Material | Material:<br>Poly(L-lactide-co-ε-caprolactone)<br>P(LA/CL)<br>Coating: | Same |

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Image /page/5/Picture/0 description: The image shows the Resorba company logo, which includes the company name in bold, capitalized letters, along with the tagline "REPAIR AND REGENERATE" in smaller letters. Below the logo, it states that Resorba is "an Advanced Medical Solutions Group plc company". In the upper right corner, the text "K181320 p. 3 of 4" is visible, likely indicating a document or page number.

Fon +49 (0) 9128/9115 0 Fax [phone]

RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberq

export @ resorba.com www.resorba.com

| | mixture of calcium stearate and<br>the copolymer of L-lactide and E-<br>caprolactone<br>Dye:<br>D&C violet No.2 | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------|
| Design | Absorbable, monofilament, dyed,<br>uncoated, provided sterile with or<br>without needles | Same |
| Sizes | Supplied in a range of USP sizes | Same |
| Performance | Meets U.S.P except for diameter | Same |
| Diameter/<br>Needle<br>attachment/<br>Tensile strength | | |
| Sterilization | Ethylene Oxide | Same |

### Performance Testing Summary:

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

- Diameter <861>
- Tensile strength <881>
- Needle attachment <871> ●

Resorption profile from in-vitro and in-vivo testing and published data has been evaluated.

Stability testing has been completed.

Results of USP performance and resorption testing demonstrate that the subject device meets USP performance requirements for absorbable sutures with the exception of minor variations in diameter from USP and is substantially equivalent to the predicate device listed.

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Image /page/6/Picture/0 description: The image shows the Resorba company logo, which includes the company name in bold black letters, with the words "REPAIR AND REGENERATE" underneath. The logo also includes an orange graphic to the left of the company name. Below the logo, it states that Resorba is "an Advanced Medical Solutions Group plc company". The text "K181320 p. 4 of 4" is located in the upper right corner of the image.

Fon +49 (0) 9128/9115 0 Fax [phone]

RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberq

export @ resorba.com www.resorba.com

Biocompatibility evaluation in accordance with ISO 10993-1 has been supported by testing on the final subject device or design and process equivalent devices.

Conclusion Based on the information provided within this 510(k) submission, Resorba Medical GmbH concludes that the CAPROLON® is substantially equivalent to the predicate device listed.