PDO Max Suture with Dual Needle

{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 17, 2021 PDO MAX, Inc. % Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738 Re: K210871 Trade/Device Name: PDO Max Suture with Dual Needle Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: November 16, 2021 Received: November 16, 2021 Dear Ms. Vater: 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 (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 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, Deborah Fellhauer RN, BSN Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K210871 Device Name PDO Max Suture with Dual Needle #### Indications for Use (Describe) The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues. Type of Use (Select one or both, as applicable) | <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:12px">☐</span> 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." {3}------------------------------------------------ # 510(k) SUMMARY This 510(k) summary of substantial equivalence information is submitted in accordance with the requirements of 21 CFR §807.92: - l. SUBMITTER PDO Max, Inc. 4971 Bear Road Liverpool, New York 13088 Tel: +1.315.427.8229 Contact Person: Giovanna McCarthy Date Prepared: December 8th, 2021 | II. DEVICE | | |------------------------------|---------------------------------------------| | Name of Device: | PDO Max Suture with Dual Needle | | Classification Name: | Suture, Surgical, Absorbable, Polydioxanone | | Regulation: | 21 CFR §878.4840 | | Regulatory Class: | Class II | | Product Classification Code: | NEW | = PREDICATE DEVICE Predicate Device Manufacturer: Predicate Device Trade Name: Predicate Device 510(k): Reference Device Manufacturer: Reference Device Trade Name: Reference Device 510(k): Angiotech Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) K120827 PDO MAX, Inc. PDS Barbed Suture, PDO MAXX Threads K190245 #### DEVICE DESCRIPTION IV. The synthetic barbed Sutures are made of polydioxanone (PDO) with needles attached to each end of the suture. The needles are straight and pre-loaded onto each end of the suture filament. The pigment for the violet dye is D&C Violet No.2. The sutures are inserted into the tissue using the needles. Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament. The suture is barbed into two sections and each section are in opposite direction. The device is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue. The Synthetic Absorbable suture with needle, approximate tissue without the need to tie surgical knots, by using the opposing barbs on the surface to embed in the tissues after the surgeon precisely places the suture within the tissues. The suture is available in 2-0, 0 and 1, suture sizes, which are the sizes identified in the currently recognized United States Pharmacopeia (USP). The needles are 50mm in length (each) and are reverse cutting type. #### V. PRINCIPLES OF OPERATION The PDO Max Suture with Dual Needle has the needles pre-attached to each end of the needle on one end is inserted into the desired tissue location and pushed through to exit the suture following behind. Suture is pulled through until the transition point (non-barbed, middle section) has {4}------------------------------------------------ reached the tissue. Estimation of the center of the device can be aided by taking a single bite of tissue, then aligning the two needles until both ends of the suture are roughly equal in length. Techniques for soft-tissue approximation may vary depending on type of tissue and closure. Once soft tissue is approximated, the surgeon ensures that the barbed section of the suture is present where the tissue approximation is desired. The excess suture length is trimmed and the needle and extra suture length are removed. Each suture has bi-directional barbs along the axis of the monofilament that allows the suture to embed in the tissue after the surgeon has placed it; therefore, there is no need to tie a surgical knot. #### VI. INDICATIONS FOR USE The PDO Max Suture with Dual Needle is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. The anatomical location(s) of use are on the skin for dermatological applications only. The suture is not intended for interior body cavity applications and the suture is not intended for lifting and supporting tissues. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence: - . Indications for Use - The predicate and subject device have similar indications for use; both are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate. - Materials The predicate and subject device are both made of polydioxanone (PDO) sutures and ● medical grade stainless steel needles. - Design The predicate and subject device are equivalent in design. They are both made of the ● same basic monofilament with similar barbs cut into the monofilament. Both the predicate and subject devices are supplied with attached needles on each end, and have bi-directional barbs. - . Performance Testing - The predicate and subject device were subjected to performance testing under the NEW product code, including in vivo animal studies to support substantial equivalence in terms of performance. | Key Feature | PDO Max Suture with Dual Needle | Predicate Device (K120827) | |-----------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Suture Material | Same as predicate | Polydioxanone (PDO) | | Suture Color | Same as predicate | Violet | | Suture Length | 200mm (USP 2-0, 0 and 1) | 200mm (USP 2-0)<br>205mm (USP 0)<br>215mm (USP 1)<br>Other USP diameter sizes<br>included in the range of 2 to 4-0. | | Needle Material | Same as predicate | Stainless steel (medical grade) | | Barb Design | Same as predicate | Bi-directional with transition<br>point in the middle | | USP Sizes | Three available sizes (USP 2-0 to 1).<br>These sizes are encompassed within<br>the available sizes for the predicate<br>device. | Variety of sizes (USP 2 to 4-0) | | Needle Length | 50mm (Same as predicate) | According to Quill's online<br>catalog, they offer a variety of<br>needle lengths and types.<br>However, the needles for sutures | The table below provides comparison of key features of the subject and predicate devices. {5}------------------------------------------------ | | | USP sizes 2-0, 0 and 1 are<br>available in 50mm lengths (as<br>indicated in the publicly<br>available online catalog). | |-------------------|-------------------|------------------------------------------------------------------------------------------------------------------------| | Needle Type | Same as predicate | Straight | | Needle Attachment | Same as predicate | Needles are pre-attached to each<br>end of the suture. | Moreover, the previously cleared PDO Max suture (K190245) is cited in this submission as a reference device. The subject device and the reference device are identical and manufacturing process. The design of the sutures is also similar, as they both have cut barbs and are bi-directional. The main difference in design between the reference and subject devices is the barb pattern. Nonetheless, PDO Max has proposed to leverage performance data from K190245 in order to support this submission. Although there are some differences in barb design between both devices, these do not impact any of the leveraged testing data. # VII. PERFORMANCE DATA The following performance testing has been conducted (or leveraged from K190245) to support determination of substantial equivalence of the subject device. This includes biocompatibility testing of the suture component, biocompatibility testing of the needle component, sterilization validation, shelf-life study, USP suture and needle performance testing (as required under the NEW product code for absorbable polydioxanone sutures) and in vivo animal testing. #### Suture Biocompatibility Testing (leveraged from K190245) - Cytotoxicity - Acute Systemic Toxicity ● - Material Mediated Pyrogenicity - Intracutaneous Reactivity Test . - Skin Sensitization Test ● - Genotoxicity - Implantation Test ● ## Needle Biocompatibility Testing - Cytotoxicity ● - Sensitization ● - Intracutaneous Irritation - Acute Systemic Toxicity ● - . Material Mediated Pyrogenicity ## Sterilization Validation (leveraged from K190245) - EO Sterilization Validation in accordance with ISO 11135:2014 ● - ucm109897 Sterilization Guidance ● #### Shelf-Life Study (leveraged from K190245) - Accelerated Aging ● #### Suture Performance Testing - Suture Absorption ● - Dimension Test ● {6}------------------------------------------------ K210871 - Tensile Strength ## Needle Performance Testing - Dimension Test - . Flexural Rigidity Test - Pierce Test . - Corrosion resistance - Needle Attachment Test ### Animal Testing (leveraged from K190245) In Vivo Biodegradation in Sprague-Dawley Rat - Absorption and Tensile Strength over time ### Barb Holding Strength Testing A barb holding strength test was conducted to compare the barb holding strength of the subject device against the predicate device. Suture samples were inserted in porcine tissue to represent skin tissue. Test results demonstrated that the barb holding strength of the subject device sutures is non-inferior to the predicate device. ### Clinical Testing Clinical testing was not required to support substantial equivalence. # VIII. CONCLUSIONS The subject device has similar indications for use to the predicate device. Moreover, both devices also have similar technological characteristics such as barb design and materials of manufacture. Appropriate performance testing was conducted (or leveraged from K190245) to support determination of substantial equivalence of the subject device. The results of this testing demonstrates that the PDO Max Suture with Dual Needle is substantially equivalent in safety and performance to the predicate device.