(118 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical properties and biocompatibility of a surgical suture, with no mention of AI or ML technology.
No.
The device is a PDS Barbed Surgical Suture, indicated for soft tissue approximation on the skin for dermatological applications. Its function is to approximate tissue, not to treat a disease or condition in a therapeutic manner.
No
The device is a surgical suture used for soft tissue approximation on the skin, not for diagnosing medical conditions.
No
The device description clearly describes a physical surgical suture made of polydioxanone (PDO) with barbs and a needle, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "soft tissue approximation where use of absorbable sutures is appropriate" and specifically on the "skin for dermatological applications only." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical suture with a needle, designed to be physically inserted into tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to help diagnose or monitor medical conditions. This device is a surgical tool used for physical repair of tissue.
N/A
Intended Use / Indications for Use
The PDS Barbed Surgical Suture 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
NEW
Device Description
PDO MAXX THREADS™ barbed sutures are made of polydioxanone (PDO) and have the colorant D&C Violet No. 2 (21 CFR 74.3602). The sutures are USP 0 suture in diameter and USP 2-0 suture in tensile strength, and 150 mm in length, swaged to a 19G/100 mm "L" Blunt needle and preloaded in a needle cannula. The sutures are inserted into the cannula/needle. The barbed sutures have cut 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. The sutures are absorbable in the body.
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 data were provided in support of the substantial equivalence determination.
Suture Biocompatibility Testing
Cytotoxicity
Irritation
Acute Systemic
Material Mediated Pyrogenicity
Genotoxicity, Carcinogenicity, and Reproductive Test
Endotoxin
Sensitization
Needle Biocompatibility Testing
Cytotoxicity
Acute Systemic
Material Mediated Pyrogenicity
Intracutaneous Reactivity Test
Skin Sensitization Test
Hemolysis Test
Suture Performance Testing
Suture Absorption
Dimension Test
Tensile Strength
Needle Performance Testing
Inner/Outside Structure
Dimension Test
Elasticity Test
Flexural Rigidity Test
Draw Test
Extraction Test
Electrical Safety and EMC Testing
Electrical safety and EMC testing were not applicable.
Animal Testing
In Vivo Biodegradation in Sprague-Dawley Rat Absorption and Tensile Strength over time
Clinical Testing
Clinical testing was not required to demonstrate the safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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June 4, 2019
PDO MAX, Inc. % Ms. Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K190245
Trade/Device Name: PDS Barbed Suture, PDO MAXX Threads Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: March 6, 2019 Received: March 6, 2019
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.
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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 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 (QS) 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 medical devices and radiation-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.
For David Krause, Ph.D. Acting Division Director Division of Infection Control and Plastic Surgery Devices 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) K190245
Device Name
PDO MAXX Threads Barbed Surgical Suture
Indications for Use (Describe)
The PDS Barbed Surgical Suture 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
K190245 pg. 1 of 3
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
SUBMITTER 1. PDO Max, Inc. 4971 Bear Road Liverpool. New York 13088 Tel: +1.315.708.9913
| Contact Person: | Giovanna McCarthy |
|---|---|
| Date Prepared: | 4 February 2019 |
- II. DEVICE Name of Device: PDO MAXX Threads Barbed Suture Classification Name: Suture, Surgical, Absorbable, Polydioxanone Regulation: 21 CFR §878.4840 Regulatory Class: Class II Product Classification Code: NEW
- III. PREDICATE DEVICE
| Predicate Manufacturer: | Feeltech Co., Ltd. |
|---|---|
| Predicate Trade Name: | Miracu |
| Predicate 510(k): | K172602 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
PDO MAXX THREADS™ barbed sutures are made of polydioxanone (PDO) and have the colorant D&C Violet No. 2 (21 CFR 74.3602). The sutures are USP 0 suture in diameter and USP 2-0 suture in tensile strength, and 150 mm in length, swaged to a 19G/100 mm "L" Blunt needle and preloaded in a needle cannula. The sutures are inserted into the cannula/needle. The barbed sutures have cut 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. The sutures are absorbable in the body.
V. INDICATIONS FOR USE
The PDS Barbed Surgical Suture 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 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 almost indications for use; both are indicated for use in soft tissue approximation where use of absorbable sutures is appropriate,
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K190245 pg. 2 of 3
specifically designed for use in the skin.
- . Materials - The predicate and subject device materials are identical.
- . 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 to the user pre-loaded in a hollow needle.
- Energy Source Neither the predicate nor the subject device requires an energy source. ●
- Performance Testing - Both the predicate and subject devices were subjected to the same biocompatibility and performance tests listed below.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Suture Biocompatibility Testing
- · Cytotoxicity
- · Irritation
- · Acute Systemic
- · Material Mediated Pyrogenicity
- · Genotoxicity, Carcinogenicity, and Reproductive Test
- Endotoxin
- · Sensitization
Needle Biocompatibility Testing
- · Cytotoxicity
- · Acute Systemic
- · Material Mediated Pyrogenicity
- · Intracutaneous Reactivity Test
- · Skin Sensitization Test
- · Hemolysis Test
Suture Performance Testing
- · Suture Absorption
- · Dimension Test
- · Tensile Strength
Needle Performance Testing
- Inner/Outside Structure
- · Dimension Test
- · Elasticity Test
- · Flexural Rigidity Test
- Draw Test
- · Extraction Test
Electrical Safety and EMC Testing
Electrical safety and EMC testing were not applicable.
Animal Testing
- In Vivo Biodegradation in Sprague-Dawley Rat Absorption and Tensile Strength over . time
Clinical Testing
Clinical testing was not required to demonstrate the safety and effectiveness.
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K190245 pg. 3 of 3
VIII. CONCLUSIONS
Based on a comparison of technological characteristics, indications for use, and performance data, it can be concluded that the proposed PDS Barbed Suture is substantially equivalent to the predicate device.