(140 days)
HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
HyperSuture Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.
The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture Extension Line". This process is for claiming substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study of its performance in a clinical setting (such as for an AI/ML device where performance metrics like sensitivity/specificity are evaluated).
The documentation does cover acceptance criteria for physical and material characteristics of the suture, and outlines how the device meets these in comparison to a predicate device. So, while it doesn't involve an AI/ML style study, I can extract information related to acceptance criteria for the suture itself and the testing performed.
Here's a breakdown of the requested information based on the provided text, focusing on the available information regarding the device's characteristics and acceptance, rather than an AI/ML performance study:
Acceptance Criteria and Study for the HyperSuture Extension Line (K234079)
This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove clinical efficacy through a multi-reader, multi-case study, or standalone algorithm performance. The "acceptance criteria" here refer to the physical and material performance specifications of the suture itself, as well as biocompatibility, to ensure it is as safe and effective as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Met by adherence to recognized standards) | Reported Device Performance (Demonstrated through testing) |
|---|---|---|
| Material Composition | UHMWPE (raw/white) and UHMWPE (Blue Dye: [Phthalocyaninato(2-)] copper for the subject device. Predicate used UHMWPE and/or Nylon). | Subject device uses White/Blue (Total 18 yarns) with sixteen (16) UHMWPE yarns and two (2) 20 denier UHMWPE yarns. Tapes are seventeen (17) UHMWPE yarns. This was compared to predicate's All White configuration (identical yarn counts) |
| Sterility | Sterile | Yes (EO Sterilization) |
| Single Use | Single Use | Yes |
| Coating Material | Uncoated | Uncoated |
| Absorbability | Nonabsorbable | Nonabsorbable |
| Construction | Braided (for cables) | Braided |
| Tape Construction | Suture Tapes are made of three distinct segments: cable section, tape section, followed by another cable section. Cable sections conform to USP diameter requirements. Tape sections have a rectangular cross-section that does not comply with USP diameter requirements. | Suture Tapes are made of three distinct segments: cable section, tape section, followed by another cable section; sections are one-third the length. Cable sections conform to USP diameter requirements, tape sections do not. |
| Sizes | Suture Cable Configuration: USP #2, USP #5. Suture Tape Configuration: Tape 1.5 (Cable sections – USP #2, Tape section width – 1.3mm ~ 1.6mm), Tape 2.5 (Cable sections – USP #5, Tape sections – 1.9mm ~ 2.3 mm) | Demonstrated to be identical to predicate's equivalent sizes, with the exception that this submission will not include the USP 2-0 size. |
| Length of Suture | 40-inch | 40-inch |
| Finish | Heat-stiffened | Heat-stiffened |
| Needle Material | AISI 302 Medical Grade Stainless Steel per ASTM F899 | AISI 302 Medical Grade Stainless Steel per ASTM F899 |
| Needle Type | 1/2 Circle, Trocar Point | 1/2 Circle, Trocar Point |
| Diameter of Suture Cables and Suture Cable Sections | Comply with diameter requirements listed in USP 43 <861> Sutures – Diameter (with the exception of the tape section of the suture tape). | Complied with USP 43 <861> Sutures – Diameter (with stated exception for tape sections). |
| Tensile Strength | Comply with tensile strength requirements listed in USP 43 <881> Tensile Strength. | Complied with USP 43 <881> Tensile Strength. |
| Needle Attachment Strength | Comply with needle attachment strength requirements listed in USP 43 <871> Sutures - Needle Attachment. | Complied with USP 43 <871> Sutures - Needle Attachment. |
| Biocompatibility | Materials evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices. | Demonstrated through testing. Blue dye ([Phthalocyaninato (2-)] copper) evaluated for biocompatibility. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each physical test (e.g., how many sutures were measured for diameter or tensile strength). However, it states that "The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength." This implies adherence to the sample size and testing methodology defined by the USP standards for those specific tests.
- Data Provenance: The document does not explicitly state the country of origin of the data. The testing appears to be non-clinical (mechanical and biocompatibility testing) and not based on prospective or retrospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of information (number and qualifications of experts for ground truth) is typically relevant for studies validating AI/ML algorithms, especially in diagnostic imaging, where human expert consensus is used to establish "true" disease presence. For this device, the "ground truth" for the physical characteristics and biocompatibility is established by adherence to recognized international and national standards (USP, ISO, ASTM).
The biocompatibility evaluation of the blue dye was conducted "by trained, board certified veterinary pathologists." The number of such pathologists is not specified.
4. Adjudication Method for the Test Set
Not applicable in the context of physical property testing or substantial equivalence claims for a medical device like a suture. Adjudication methods (e.g., 2+1, 3+1) are primarily used in clinical studies where human readers provide interpretations (e.g., radiology reads) and their disagreements need to be resolved to establish ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is relevant for evaluating the performance of AI-assisted systems in diagnostic scenarios (e.g., whether AI improves a radiologist's accuracy). This submission is for a surgical suture, which is a physical medical device, not an AI/ML algorithm.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
No. This concept is applicable to AI/ML algorithms. The HyperSuture Extension Line is a physical surgical suture. The "performance" assessment refers to its physical and material properties, not an algorithmic output.
7. The Type of Ground Truth Used
The "ground truth" for the device's characteristics (diameter, tensile strength, biocompatibility, etc.) is established by:
- Established Standards: Compliance with United States Pharmacopeia (USP) standards (USP 43 <861> for Diameter, <881> for Tensile Strength, <871> for Needle Attachment).
- International Standards: Compliance with ISO 10993-1:2009 for Biological Evaluation of Medical Devices.
- Material Specifications: Adherence to material specifications (e.g., AISI 302 Medical Grade Stainless Steel per ASTM F899 for needles).
- Expert Evaluation: Biocompatibility evaluation of the blue dye was assessed by trained, board-certified veterinary pathologists.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of medical device submission.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 10, 2024
Threadstone L.L.C. Jeremy Clark President 1035 Benfield Blvd, Suite H Millersville, Maryland 21108
Re: K234079
Trade/Device Name: HyperSuture Extension Line Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: April 9, 2024 Received: April 9, 2024
Dear Jeremy Clark:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.05.10 12:17:20
12:17:20 Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
HyperSuture Extension Line
Indications for Use (Describe)
HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic 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)
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510(k) Summary of Threadstone HyperSuture™ Extension Line (K234079)
Submitter Information
| Applicant: | Threadstone L.L.C. |
|---|---|
| Address: | 1035 Benfield Blvd, Suite H,Millersville, MD 21163, USA |
| Phone Number: | 443-790-6536 |
| Fax Number: | N/A |
| Registration Number: | 3017499940 |
| Contact Person: | Jeremy ClarkOffice@Threadstoneusa.com |
| Date of Preparation: | 08MAY2024 |
| Device Name | |
| Trade Name: | HyperSuture™ Extension Line |
| Common or Usual Names: | Polyblend Suture, Non-absorbable Surgical Sutures |
| Classification Name: | Nonabsorbable poly(ethylene terephthalate) SurgicalSuture |
| Device Classification | |
| FDA Class: | II |
| Product Classification: | 21 CFR 878.5000Suture, nonabsorbable, synthetic, polyethylene |
| Classification Code: | GAT |
| Review Panel: | General & Plastic Surgery |
| Premarket Review: | Office of Device EvaluationDivision of Surgical Devices, Plastic and ReconstructiveGeneral Surgery Devices Branch |
K230311 – HyperSuture™ (GAT – 21 CFR 878.5000 Suture, nonabsorbable, synthetic, polyethylene)
Predicate Device
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Device Description Summary:
HyperSuture Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.
Intended Use / Indication for Use:
HyperSuture Extension Line sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
Substantial Equivalence Summary:
The Threadstone HyperSuture Extension Line devices are substantially equivalent to the predicate devices as the features and intended uses are the same. The HyperSuture Extension Line devices have the same principles of operation and similar technical characteristics as the predicate device. Biocompatibility testing and mechanical testing have been conducted, including implantation studies, chemical characterization, toxicology assessments, length, diameter, tensile strength, and needle attachment strength, to demonstrate that the proposed product has met the acceptance criteria for the proposed indications.
Technical Characteristic Comparison Chart:
| Characteristics | Subject Device | Predicate Device | Substantial Equivalence |
|---|---|---|---|
| HyperSuture™ Extension Line | HyperSuture™ | ||
| 510(k) Number | K234079 | K230311 | N/A |
| Product Code | GAT | GAT | Identical |
| Regulation No. | 21 CFR 878.5000Suture, nonabsorbable, synthetic,polyethylene | 21 CFR 878.5000Suture, nonabsorbable, synthetic,polyethylene | Identical |
| Class | II | II | Identical |
| Sterile | Yes (EO Sterilization) | Yes (EO Sterilization) | Identical |
| Single Use | Yes | Yes | Identical |
| Indication for Use | For use in general soft tissueapproximation and/or ligation,including use in cardiovascular,and the use of allograft tissue fororthopedic procedures. | For use in general soft tissueapproximation and/or ligation,including use in cardiovascular,and the use of allograft tissue fororthopedic procedures. | Identical |
| Configurations | Cable and Tape with or withoutneedle attached | Cable and Tape with or withoutneedle attached | Identical |
| Cable Material | White/Blue (Total 18 yarns)Cables are made from sixteen(16) UHMWPE yarns with two (2)20 denier UHMWPE yarns | White/Black (Total 18 yarns)Cables are made from fourteen(14) UHMWPE yarns and two (2)Nylon yarns with two (2) 20denier UHMWPE yarnsAll White (Total 18 yarns)Cables are made from sixteen(16) UHMWPE yarns with two (2)20 denier UHMWPE yarns | Yes, the number of UHMWPEyarns is identical to that of the AllWhite configuration. Eighteen (18)Total. |
| Tape Material | White/Blue (Total 17 yarns)Tapes are made from seventeen(17) UHMWPE | White/Black (Total 17 yarns)Tapes are made fifteen (15)UHMWPE yarns and two (2)Nylon yarnsAll White (Total 17 yarns)Tapes are made from seventeen(17) UHMWPE | Yes, the number of UHMWPEyarns is identical to that of the AllWhite configuration. Seventeen(17) Total. |
| Cable DenierSelection | Denier used in the suture isdetermined by the USP size of thesuture. | Denier used in the suture isdetermined by the USP size of thesuture. | Identical |
| Tape DenierSelection | Denier used in the suture isdetermined by the USP sizeequivalent of the suture tape.Ex. USP #2 (1.5 tape) andUSP #5 (2.5 tape) | Denier used in the suture isdetermined by the USP sizeequivalent of the suture tape.Ex. USP #2-0 (0.5 tape), USP #2(1.5 tape) and USP #5 (2.5 tape) | Identical, this submission will notinclude the USP 2-0 size |
| Dye Information | Blue is [Phthalocyaninato (2-)]copper < 0.5% by weight per 21CFR 74.3045White UHMWPE is raw/natural. | Black is Logwood Extract < 1.0%by weight per 21 CFR 73.1410.White UHMWPE is raw/natural. | The candidate device uses bluedye which is made of[Phthalocyaninato (2-)] copper < 0.5% by weight per 21 CFR74.3045 dye. This has been testedfor biocompatibility.White UHMWPE is raw/natural andidentical in both the predicate andcandidate device. |
| Coating Material | Uncoated | Uncoated | Identical |
| Absorbability | Nonabsorbable | Nonabsorbable | Identical |
| Braided/Monofilament | Braided | Braided | Identical |
| Tape Construction | Suture Tapes are made of threedistinct segments: cable section,tape section, followed by anothercable section so that each sectionis a third of the length of thesuture tape.Cable sections conform to USPdiameter requirements.Tape sections have a rectangularcross-section that does notcomply with USP diameterrequirements. | Suture Tapes are made of threedistinct segments: cable section,tape section, followed by anothercable section so that each sectionis a third of the length of thesuture tape.Cable sections conform to USPdiameter requirements.Tape sections have a rectangularcross-section that does notcomply with USP diameterrequirements. | Identical |
| Sizes | Suture Cable Configuration:USP #2, USP #5Suture Tape Configuration:Tape 1.5:Cable sections – USP #2Tape section width –1.3mm ~ 1.6mm | Suture Cable Configuration:USP 2-0, USP #2, USP #5Suture Tape Configuration:Tape 0.5:Cable sections – USP 2-0 | Identical, this submission will notinclude the USP 2-0 size |
| Tape 2.5Cable sections –USP #5Tape sections – 1.9mm ~2.3 mm | Tape section width –0.7mm ~ 0.85 mmTape 1.5:Cable sections – USP#2Tape section width –1.3mm | ||
| Length of Suture | 40-inch | 40-inch | Identical |
| Finish | Heat-stiffened | Heat-stiffened | Identical |
| Needle Material | AISI 302 Medical Grade StainlessSteel per ASTM F899 | AISI 302 Medical Grade StainlessSteel per ASTM F899 | Identical |
| Needle Type | 1/2 Circle, Trocar Point | 1/2 Circle, Trocar Point | Identical |
| Diameter of SutureCables and SutureCable Sections | The suture diameters of theproposed devices comply with thediameter requirements listed inUSP 43 <861> Sutures –Diameter with the exception of thetape section of the suture tape. | The suture diameters of theproposed devices comply with thediameter requirements listed inUSP 43 <861> Sutures –Diameter with the exception ofthe tape section of the suturetape. | Identical |
| Tensile Strength | Both cables and tapes complywith the tensile strengthrequirements listed in USP 43<881> Tensile Strength. | Both cables and tapes complywith the tensile strengthrequirements listed in USP 43<881> Tensile Strength. | Identical |
| Needle Attachment | The needle attachment strengthsbetween suture and needle of theapplicable devices (suture andtape) comply with the needleattachment strength requirementslisted in USP 43 <871> Sutures -Needle Attachment. | The needle attachment strengthsbetween suture and needle of theapplicable devices (suture andtape) comply with the needleattachment strength requirementslisted in USP 43 <871> Sutures -Needle Attachment. | Identical |
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Device Comparison Discussion:
Substantial equivalence between the Threadstone HyperSuture Extension Line and the Threadstone HyperSuture (K230311) can be demonstrated according to the FDA's guidelines for substantial equivalence decision making process for at least the following reasons:
-
- The Threadstone HyperSuture Extension Line has equivalent intended use and indications as the Threadstone HyperSuture (K230311)
-
- Major technological characteristics are substantially equivalent between the Threadstone HyperSuture Extension Line and the Threadstone including, but not limited to:
- a. Substantially equivalent materials
- b. Substantially equivalent size range
- c. Substantially equivalent method of use
- d. Substantially equivalent mechanical strength
The Threadstone HyperSuture (K230311) are also made from UHMWPE material (raw/white) and/or a combination of UHMWPE material (raw/white) and Nylon (black). The Threadstone HyperSuture extension line is made from a combination of UHMWPE material (raw/white) and UHMWPE (Blue Dye: [Phthalocyaninato(2-)] copper) which has been evaluated for biocompatibility by trained, board certified veterinary pathologists.
Non-Clinical Testing Summary:
The Threadstone HyperSuture™ Extension Line sutures (both cables and tapes) meet requirements established by the United States Pharmacopeia (USP). The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength. Materials were evaluated per ISO 10993-1:2009 -Biological Evaluation of Medical Devices. The Threadstone HyperSuture™ Extension Line products demonstrated substantial equivalence to the Threadstone HyperSuture™ products.
Conclusion:
Based on the results of completed performance testing inclusive of physical testing, biocompatibility testing, it can be concluded that the Threadstone HyperSuture™ Extension Line is substantially equivalent in terms of safety and effectiveness to HyperSuture™
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.