(268 days)
No
The description focuses on the physical properties and function of a barbed suture and needle, with no mention of AI or ML.
No
The device is described as an absorbable suture used for soft tissue approximation on the skin for dermatological applications. It is not indicated for treating or curing a disease or condition, but rather for facilitating repair by holding tissue together.
No
The device is a barbed suture used for soft tissue approximation on the skin for dermatological applications. It is a tool for treatment (tissue approximation) rather than for diagnosing a condition or disease.
No
The device description clearly details a physical medical device (suture with needles) made of polydioxanone, intended for soft tissue approximation. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The PDO Max Suture with Dual Needle is a surgical suture intended for soft tissue approximation on the skin. It is physically inserted into the body to hold tissues together. This is an in vivo application, not an in vitro one.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic purpose. Its function is purely mechanical – to approximate tissue.
Therefore, this device falls under the category of a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin for dermatological applications only.
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)
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
- 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.
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.
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.
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
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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
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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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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) |
| 205mm (USP 0) | ||
| 215mm (USP 1) | ||
| Other USP diameter sizes | ||
| 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 |
| point in the middle | ||
| USP Sizes | Three available sizes (USP 2-0 to 1). | |
| These sizes are encompassed within | ||
| the available sizes for the predicate | ||
| device. | Variety of sizes (USP 2 to 4-0) | |
| Needle Length | 50mm (Same as predicate) | According to Quill's online |
| catalog, they offer a variety of | ||
| needle lengths and types. | ||
| 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
available in 50mm lengths (as
indicated in the publicly
available online catalog). |
|-------------------|-------------------|------------------------------------------------------------------------------------------------------------------------|
| Needle Type | Same as predicate | Straight |
| Needle Attachment | Same as predicate | Needles are pre-attached to each
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
- 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.