1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue. April 25, 2024 M/s. Meril Endo Surgery Private Limited Asma Shaikh Assistant Manager- Regulatory Affairs Third Floor, E1-E3, Meril Park Survey No. 135/2/B & 174/2. Muktanand Marg. Chala Vapi, Gujarat 396191 India Re: K232246 Trade/Device Name: 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture: 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW, GAM Dated: July 28, 2023 Received: March 25, 2024 Dear Asma Shaikh: 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. {1}------------------------------------------------ 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). 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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for {2}------------------------------------------------ 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: 2024.04.25 15:43:22 -04'00' 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 {3}------------------------------------------------ ### Indications for Use Submission Number (if known) K232246 Device Name 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture Indications for Use (Describe) 1. PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. 2. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. 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." {4}------------------------------------------------ #### I. SUBMITTER M/s. Meril Endo Surgery Private Limited. Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com #### Applicant Information Mr. Umesh Sharma General Manager – Quality Assurance / Regulatory Affairs E-mail: umesh.sharma@merillife.com #### Primary Correspondent Information Asma Shaikh Assistant Manager – Regulatory Affairs E-mail: asma.shaikh@merillife.com Date Prepared: April 24th, 2024 ### II. SUBJECT DEVICE | Trade / Proprietary Name | PINION™ PDO Knotless Suture | |--------------------------|--------------------------------------------| | Common Name | Suture, Surgical, Absorbable Polydioxanone | | Classification | Absorbable Polydioxanone Surgical Suture | | Regulatory Class | II | | Product Code | NEW | | Regulation Number | 21 CFR 878.4840 | | Review Panel | General & Plastic Surgery Devices Panel | {5}------------------------------------------------ | Trade / Proprietary Name | PINION™ PGA-PCL Knotless Suture | |--------------------------|------------------------------------------------------| | Common Name | Suture, Surgical, Absorbable Polyglycolic Acid | | Classification | Absorbable poly(glycolide/l-lactide) surgical suture | | Regulatory Class | II | | Product Code | GAM | | Regulation Number | 21 CFR 878.4493 | | Review Panel | General & Plastic Surgery Devices Panel | ### III. PREDICATE DEVICE | Subject device<br>(K232246) | Trade Name | Predicate device<br>Manufacturer | 510 (K) No. | |------------------------------------|--------------------------------------------------------------------------------------------|----------------------------------|-------------| | PINION™ PDO<br>Knotless Suture | STRATAFIX™ Symmetric<br>PDS™ Plus Knotless Tissue<br>Control Device | Ethicon Inc. | K182873 | | PINION™ PGA-PCL<br>Knotless Suture | STRATAFIX™ Spiral<br>MONOCRYL™ Knotless<br>Tissue Control<br>Device(Primary Predicate) | Ethicon Inc. | K151200 | | | STRATAFIX™ Spiral<br>MONOCRYL™ Plus<br>Unidirectional Knotless<br>Tissue<br>Control Device | | K221744 | ### IV. Device Description #### PINION™ PDO KNOTLESS SUTURE The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a {6}------------------------------------------------ surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. The USP designations for diameter are applicable to the PINION™ PDO Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PDO Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PDO Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size. The non-barbed size and equivalent size of the PINION™ PDO Knotless Suture is further clarified in Table 1. The maximum oversize for non barbed suture material from the USP Size is further detailed in Table 2. The PINION™ PDO Knotless Suture meets requirements established by the United States Pharmacopoeia (USP) for Synthetic absorbable sutures for needle attachments only. | PINION™ PDO<br>Knotless Suture | Pre-Barbing Suture Size | Equivalent Non-barbed<br>Suture Size<br>(USP)/Tensile Strength<br>(kgf) | |--------------------------------|-------------------------|-------------------------------------------------------------------------| | 3-0 | 2-0 | 3-0/1.77 | | 2-0 | 0 | 2-0/2.68 | | 0 | 1 | 0/3.90 | #### Tensile Strength/Size Equivalency Table 1 Maximum Oversize for non-barbed suture material in diameter (mm) from USP Table 2 | PINION™ PDO<br>Knotless Suture | USP Size Designations<br>(mm) | PINION™ PDO<br>Knotless Suture<br>Diameter Specification<br>(mm) | |--------------------------------|-------------------------------|------------------------------------------------------------------| | 3-0 | 0.200-0.249 | 0.300-0.349 | | 2-0 | 0.300-0.349 | 0.350-0.399 | | 0 | 0.350-0.399 | 0.400-0.499 | The PINION™ PDO Knotless Suture is MR Safe. #### PINION™ PGA-PCL KNOTLESS SUTURE The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). {7}------------------------------------------------ PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots. The USP designations for diameter are applicable to the PINION™ PGA-PCL Knotless Suture material prior to barbing. After the creation of barbs, the PINION™ PGA-PCL Knotless Suture is identified as one size smaller than the non-barbed suture. This modification reduces the tensile strength of the suture similar to effect of knot tying in non-barbed suture. Therefore, the straight pull tensile strength of the PINION™ PGA-PCL Knotless Suture is comparable to the USP knot pull tensile strength for a non barbed suture of the equivalent size. The non-barbed size and equivalent size of the PINION™ PGA-PCL Knotless Suture is further clarified in Table 1. The maximum oversize for non barbed suture material from the USP Size is further detailed in Table 2. The PINION™ PGA-PCL Knotless Suture meets requirements established by the United States Pharmacopoeia (USP) for Synthetic absorbable sutures for needle attachments only. |--| | PINION™ PGA-<br>PCL Knotless<br>Suture | Pre-Barbing Suture Size | Equivalent Non-barbed<br>Suture Size<br>(USP)/Tensile Strength<br>(kgf) | |----------------------------------------|-------------------------|-------------------------------------------------------------------------| | 4-0 | 3-0 | 4-0/0.95 | | 3-0 | 2-0 | 3-0/1.77 | | 2-0 | 0 | 2-0/2.68 | Maximum Oversize for non-barbed suture material in diameter (mm) from USP Table 2 | PINION™ PGA-<br>PCL Knotless<br>Suture | USP Size Designations<br>(mm) | PINION™ PGA-PCL<br>Knotless Suture<br>Diameter Range (mm) | |----------------------------------------|-------------------------------|-----------------------------------------------------------| | 4-0 | 0.150-0.199 | 0.200-0.249 | | 3-0 | 0.200-0.249 | 0.300-0.349 | | 2-0 | 0.300-0.349 | 0.350-0.399 | The PINION™ PGA-PCL Knotless Suture is MR Safe. {8}------------------------------------------------ ### V. Indications for Use PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate. ### VI. Comparison of Technological Characteristics with the predicate device The PINION™ PDO & PINION™ PGA-PCL Knotless Sutures are substantially equivalent to marketed predicate device with respect to intended use and physical characteristics. The PINION™ PGA-PCL Knotless Sutures have same material, mechanism of action, performance and packaging as predicate devices. The following characteristics were compared between the subject device and the predicate device in order to demonstrate the substantial equivalence. {9}------------------------------------------------ The below table provides the comparison of key features of the subject device and predicate devices. #### Table 1: PINION™ PDO Knotless Suture | Sr.<br>No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | | |------------|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Device Name | PINION™ PDO Knotless Suture | STRATAFIX™ Symmetric PDS™ Plus<br>Knotless Tissue Control Device | - | | | 2. | Manufacturer | Meril EndoSurgery Pvt. Ltd. | Ethicon Inc. | - | | | 3. | 510(K) Number | K232246 | K182873 | - | | | 4. | Common Name | Absorbable Polydioxanone surgical<br>suture | Absorbable Polydioxanone surgical<br>suture | No change | | | 5. | Class | II | II | No change | | | 6. | Product Code | NEW | NEW | No change | | | 7. | Regulation Number | CFR 878.4840 | CFR 878.4840 | No change | | | 8. | Intended use | PINION™ PDO Knotless Suture is<br>indicated for use in general soft tissue<br>approximation where use of an<br>absorbable suture use is appropriate. | STRATAFIX™ Symmetric PDS™ Plus<br>Knotless Tissue Control Devices are<br>indicated for general soft tissue<br>approximation where use of an<br>absorbable suture is appropriate. | Identical | | | 9. | For single use only | Single use only | Single use only | No change | | | 10 | Mode of Actions | Two important characteristics<br>describe the in vivo performance of<br>absorbable sutures: first, tensile<br>strength retention and second, the<br>absorption rate (loss of mass).<br>PINION™ PDO Knotless Suture has<br>been formulated to minimize the<br>variability of these characteristics and<br>to provide wound support through<br>the critical wound healing period and | Two important characteristics describe<br>the in vivo performance of absorbable<br>sutures: first, tensile strength retention<br>and second, the absorption rate (loss<br>of mass). STRATAFIX™ Symmetric<br>PDS™ Plus Knotless Tissue Control<br>Devices has been formulated to<br>minimize the variability of these<br>characteristics and to provide wound<br>support through the critical wound | Identical | | | | K232246 | | | | | | Sr.<br>No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | | | | | an extended healing period.<br>The results of in vitro study using<br>PINION™ PDO Knotless Suture<br>indicate that approximately 70-80% of<br>the original strength remains after<br>two weeks and four weeks of study.<br>At six weeks approximately 40-50% of<br>the original strength is retained.<br>The absorption of PINION™ PDO<br>Knotless Suture is minimal until about<br>120 days and complete absorption<br>usually takes place within 180 days<br>(six months). | healing period and an extended<br>healing period.<br>The results of implantation studies in<br>animals using STRATAFIX™ Symmetric<br>PDS™ Plus Knotless Tissue Control<br>Devices indicates that for sizes 3-0 and<br>larger, approximately 80 % of the<br>original strength remains after two<br>weeks and four weeks of implantation.<br>At six weeks post implantation,<br>approximately 40% to 70% of the<br>original strength is retained. For Size 4-<br>0, approximately 67 % of the original<br>tensile strength remains after two<br>weeks, approximately 50% at 4 weeks,<br>and approximately 37 % at 6 weeks.<br>Data obtained from implantation<br>studies show that absorption of<br>STRATAFIX™ Symmetric PDS™ Plus<br>Knotless Tissue Control Devices is<br>minimal until about 120 days and is<br>essentially complete within 180 days<br>(six months). | | | | 11 | Material composition | poly (p-dioxanone) | poly (p-dioxanone) | No change | | | 12 | Body Contact | Tissue/Bone/Blood | Tissue/Bone/Blood | No change | | | 13 | Shelf Life | 5 Year | 5 Year | No change | | | 14 | Size availability | 3-0 to 0 | 3-0 to 1 | Identical; Suture size is<br>covered by the<br>Predicate Suture Range | | | 15 | Absorbable/Non Absorbable | Absorbable | Absorbable | No change | | | 16 | Braided/ | Monofilament | Monofilament | No change | | | Sr.<br>No. | Characteristics | Subject Device | Predicate Device | Safety / Effectiveness | | | | Monofilament | | | | | | 17 | Dyed / Undyed | Undyed or Dyed Suture Strands | Undyed or Dyed Suture Strands | No change | | | 18 | Colorant | D&C Violet No. 2 | D&C Violet No. 2 | No change | | | 19 | Coated / Uncoated | Uncoated | Uncoated | No change | | | 20 | Types of Barbs | Uni-directional, Bi-directional | Uni-directional, Bi-directional | No change | | | 21 | No. of barbs per linear length<br>of Suture | 13-17 barbs per cm | 10 barbs per cm | No. of Barbs is more in<br>subject device than<br>predicate device which<br>provides more safety to<br>device. | | | 22 | Barb Angle | 3-0 | | Different; While there are<br>difference in cut angle<br>between the subject device<br>and the predicate device, these<br>do not raise the new questions<br>of safety and effectiveness<br>as the average barb holding<br>strength for the subject is<br>equivalent to that of the<br>predicate device. | | | | | 2-0 | $40-50 (∠°)$ | | $23 -28 (∠°)$ | | | | 0 | $35-45 (∠°)$ |…