(123 days)
N18331
No
The device description and performance studies focus on the physical and mechanical properties of a surgical suture, with no mention of AI or ML technology.
No
A therapeutic device is one that treats a disease or condition. This device is a surgical suture used for approximation and ligation of tissues. While it aids in the healing process, it doesn't actively treat a disease or condition itself.
No
Explanation: CAPROLON® is a surgical suture used for tissue approximation and/or ligation. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a 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," which is a surgical procedure performed directly on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a surgical suture, a material used to close wounds or tie off blood vessels during surgery. This is a physical implant/tool used in a surgical setting, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
Therefore, CAPROLON® is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
CAPROLON® is a synthetic absorbable surgical suture. 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Tensile strength
- Needle attachment ●
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.
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.
Monograms Gramsmed K010672
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.
PDS II Ethicon N18331
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
§ 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.
0
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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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) |
|---|
| ☑ 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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3
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 +49 (0) 9128/9115 91
RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberg
export @ resorba.com www.resorba.com
510(k) Summary Statement
| Submitted by: | Resorba Medical GmbH
Am Flachmoor 16
90475 Nuremberg
Germany
Tel: +49 9128-9115-0
Fax: +49 9128-9115-10 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
Date of Summary: | Helen Topping
16th May 2018 |
| Trade Name | CAPROLON® |
| Common Name | Suture, absorbable, synthetic, polyglycolic acid |
| Classification
Name | Absorbable poly(glycolide/l-lactide) surgical suture |
| Regulation
Classification | 21 CFR §878.4493 |
| Product Code | GAM |
| Class of device | II |
| Predicate device | Monograms Gramsmed K010672 |
| Reference
Predicate | PDS II Ethicon N18331 |
4
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 +49 (0) 9128/9115 91
RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberg
export @ resorba.com www.resorba.com
| Device
Description: | CAPROLON® is a synthetic absorbable surgical suture.
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
ligation, including use in ophthalmic procedures, but not for use in
cardiovascular and neurological procedures. |
| Substantial
Equivalence: | CAPROLON® has the same intended use and similar design, materials, labeling
performance characteristics to its predicate device |
| Technological
characteristics | CAPROLON® is substantially equivalent to the predicate device listed when
compared to the technological characteristics of primary material, material
presentation, dye, coating and are supplied sterile for single use. All meet USP
requirements except for variations in diameter. The subject and predicate
sutures are manufactured from the identical material from the same material
supplier. |
Comparison of technological characteristics to predicate device:
| Characteristic | CAPROLON® | Monograms
K010672 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Intended Use | 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 | Same |
| Material | Material:
Poly(L-lactide-co-ε-caprolactone)
P(LA/CL)
Coating: | Same |
5
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 +49 (0) 9128/9115 91
RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberq
export @ resorba.com www.resorba.com
| | mixture of calcium stearate and
the copolymer of L-lactide and E-
caprolactone
Dye:
D&C violet No.2 | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|------|
| Design | Absorbable, monofilament, dyed,
uncoated, provided sterile with or
without needles | Same |
| Sizes | Supplied in a range of USP sizes | Same |
| Performance | Meets U.S.P except for diameter | Same |
| Diameter/
Needle
attachment/
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
- Tensile strength
- Needle attachment ●
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.
6
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 +49 (0) 9128/9115 91
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.