(123 days)
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
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.
The provided text describes the 510(k) submission for CAPROLON®, an absorbable poly(glycolide/l-lactide) surgical suture. The review determined that the device is substantially equivalent to a legally marketed predicate device. The document does not describe a study involving an AI or an algorithm. Instead, it outlines the performance testing for a medical device (surgical suture) against established USP (United States Pharmacopeia) standards. Therefore, an answer to your request regarding AI/algorithm-specific acceptance criteria and studies cannot be fully provided from the given text.
However, I can extract information regarding the device's acceptance criteria and performance based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (from USP Monograph for Synthetic Absorbable Sutures) | Reported Device Performance (CAPROLON®) |
|---|---|---|
| Diameter | Meets U.S.P requirements | Meets U.S.P requirements except for minor variations |
| Tensile Strength | Meets U.S.P requirements | Meets U.S.P requirements |
| Needle Attachment | Meets U.S.P requirements | Meets U.S.P requirements |
| Resorption Profile | N/A (evaluated from in-vitro/in-vivo testing and published data) | Evaluated and determined to be acceptable |
| Stability | N/A (testing completed) | Testing completed and results acceptable |
| Biocompatibility | In accordance with ISO 10993-1 | Supported by testing on the final subject device or design/process equivalent devices |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the document. The text only mentions "the subject device was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph." Specific numbers of sutures tested for each characteristic (Diameter, Tensile strength, Needle attachment) are not provided.
- Data Provenance: The testing was conducted by Resorba Medical GmbH as part of their 510(k) submission. The document doesn't specify country of origin for the raw data, but the company is based in Germany. The testing appears to be conducted specifically for this submission, implying a prospective nature in the context of this regulatory filing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the evaluation of a surgical suture against USP standards. "Ground truth" in this context refers to the defined parameters and methods set forth by the USP, which are established by expert consensus over time within the pharmaceutical and medical device industries. The testing itself is quantitative and objective, not reliant on expert interpretation for its results.
4. Adjudication method for the test set:
- Not applicable in the context of quantitative USP testing. Results are compared directly against predefined numerical and qualitative standards from the USP monograph.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This query is not applicable. The document is about a surgical suture, not an AI or algorithm-based diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This query is not applicable. The document is about a surgical suture, not an AI or algorithm.
7. The type of ground truth used:
- The "ground truth" used for this device's performance evaluation comprises the United States Pharmacopeia (USP) Monograph for Synthetic Absorbable Sutures and ISO 10993-1 for Biocompatibility. These are established, validated, and legally recognized standards that define acceptable performance characteristics for medical devices like surgical sutures.
8. The sample size for the training set:
- This query is not applicable. The document describes a physical medical device (suture) and its performance testing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- This query is not applicable as there is no AI algorithm or training set discussed.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
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 (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
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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) |
|---|
| ☑ 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 +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 GmbHAm Flachmoor 1690475 NurembergGermanyTel: +49 9128-9115-0Fax: +49 9128-9115-10 |
|---|---|
| Contact Person:Date of Summary: | Helen Topping16th May 2018 |
| Trade Name | CAPROLON® |
| Common Name | Suture, absorbable, synthetic, polyglycolic acid |
| ClassificationName | Absorbable poly(glycolide/l-lactide) surgical suture |
| RegulationClassification | 21 CFR §878.4493 |
| Product Code | GAM |
| Class of device | II |
| Predicate device | Monograms Gramsmed K010672 |
| ReferencePredicate | 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 +49 (0) 9128/9115 91
RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberg
export @ resorba.com www.resorba.com
| DeviceDescription: | 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/orligation, including use in ophthalmic procedures, but not for use incardiovascular and neurological procedures. |
| SubstantialEquivalence: | CAPROLON® has the same intended use and similar design, materials, labelingperformance characteristics to its predicate device |
| Technologicalcharacteristics | CAPROLON® is substantially equivalent to the predicate device listed whencompared to the technological characteristics of primary material, materialpresentation, dye, coating and are supplied sterile for single use. All meet USPrequirements except for variations in diameter. The subject and predicatesutures are manufactured from the identical material from the same materialsupplier. |
Comparison of technological characteristics to predicate device:
| Characteristic | CAPROLON® | MonogramsK010672 |
|---|---|---|
| Intended Use | Indicated for use in general softtissue approximation and/orligation, including use inophthalmic procedures, but notfor use in cardiovascular andneurological procedures | Same |
| Material | Material:Poly(L-lactide-co-ε-caprolactone)P(LA/CL)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 +49 (0) 9128/9115 91
RESORBA Medical GmbH. Am Flachmoor 16 . 90475 Nürnberq
export @ resorba.com www.resorba.com
| mixture of calcium stearate andthe copolymer of L-lactide and E-caprolactoneDye:D&C violet No.2 | ||
|---|---|---|
| Design | Absorbable, monofilament, dyed,uncoated, provided sterile with orwithout needles | Same |
| Sizes | Supplied in a range of USP sizes | Same |
| Performance | Meets U.S.P except for diameter | Same |
| Diameter/Needleattachment/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 +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.
§ 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.