(149 days)
Sharpoint® PDO sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular, or neurological tissues, microsurgery or ophthalmic surgery.
The Sharpoint® (Polydioxanone) PDO Suture is a synthetic, absorbable, monofilament surgical suture available dyed D&C violet No.2. The PDO Sutures are attached to various size needles made of 400 series stainless steel
The provided text is a 510(k) summary for a medical device (Sharpoint® PDO Sutures) and does not describe a study involving AI, image analysis, or human readers. Instead, it describes a traditional medical device submission for a surgical suture.
Therefore, many of the requested categories (like "Sample sized used for the test set and the data provenance," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set sample size," and "Ground truth for training set") are not applicable to this document.
However, I can extract the acceptance criteria and performance data as presented for this type of medical device submission.
Acceptance Criteria and Reported Device Performance for Sharpoint® PDO Sutures
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Characteristics | Well-characterized polydioxanone material. | "The Polydioxanone material is well characterized through absorption studies and biocompatibility studies." |
| Safety & Effectiveness | Device demonstrated to be safe and effective. | "Bench testing has demonstrated the device to be safe and effective." |
| Equivalency to Predicate | Performance equivalent to the predicate device, Ethicon PDS II. | "Its performance is equivalent to the predicate device, Ethicon PDS II." and "The Sharpoint® PDO sutures are equivalent to the predicate device PDS II in material composition, intended use, absorption profile and bench testing." |
| Physical Testing | Conformance to USP 29 standards for Suture Diameter, Suture Attachment, Tensile Strength. | "Physical testing was performed on PDO (Polydioxanone) Synthetic, Absorbable sutures to USP 29, including <861> Suture Diameter, <871> Suture Attachment, <881> Tensile Strength." |
| Biocompatibility | Conformance to ISO 10993 for Biocompatibility. | "Animal testing was performed for conformance to ISO 10993 for Biocompatibility..." |
| Implant Studies | Demonstration of rates of tensile and mass loss (absorption profile). | "...and Implant studies to demonstrate rates of tensile and mass loss." |
Additional Information (Not Directly Applicable to AI/Image Analysis)
- Sample sized used for the test set and the data provenance: Not explicitly stated in terms of specific numbers for physical or animal testing, but the provenance is internal testing by the manufacturer.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for sutures is based on objective physical measurements and biological responses.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not relevant for suture validation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used:
- Physical Properties: Established by validated laboratory measurement methods (e.g., USP standards for diameter, tensile strength).
- Biocompatibility/Absorption: Established through in-vivo animal testing according to ISO 10993.
- The sample size for the training set: Not applicable (no "training set" in the AI sense).
- How the ground truth for the training set was established: Not applicable.
This document describes a regulatory submission for a conventional medical device (surgical sutures) where the validation relies on established international standards, bench testing, and animal studies to demonstrate safety, effectiveness, and substantial equivalence to a predicate device. It does not involve any artificial intelligence, machine learning, or human-in-the-loop evaluation as typically seen in AI/image analysis device submissions.
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MAY - 9 2007
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| Submitter: | Surgical Specialties Corporation dba Angiotech |
|---|---|
| Address: | 100 Dennis DriveReading, PA 19606 |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth LazaroRegulatory Affairs Specialist |
| Date Prepared: | December 6, 2006 revised May 07, 2007 |
| Name of Device: | Sharpoint® PDO ( Polydioxanone) Synthetic,Absorbable, Monofilament Sutures |
| Common / UsualClassification Name: | Surgical Suture.Absorbable Polydioxanone Surgical Suture. |
| Regulation Number: | 878.4840 |
| Device Classification: | Class II Device |
| Predicate Device: | Ethicon's PDS IISubmission Number N18331 |
| Device Description | The Sharpoint® (Polydioxanone) PDO Suture is asynthetic, absorbable, monofilament surgical sutureavailable dyed D&C violet No.2. The PDO Suturesare attached to various size needles made of 400series stainless steel |
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Intended Use: | The Sharpoint® PDO Sutures are indicated for usein general soft tissue approximation and/or ligation,but not for use in cardiovascular or neurologicaltissues, microsurgery or ophthalmic surgery. |
|---|---|
| Technological Characteristics: | The Polydioxanone material is well characterizedthrough absorption studies and biocompatibilitystudies.Bench testing has demonstrated the device to besafe and effective. Its performance is equivalent tothe predicate device, Ethicon PDS II. |
| Performance Data: | Physical testing was performed on PDO(Polydioxanone) Synthetic, Absorbable sutures toUSP 29, including <861> Suture Diameter, <871>Suture Attachment, <881> Tensile Strength. Animaltesting was performed for conformance to ISO10993 for Biocompatibility and Implant studies todemonstrate rates of tensile and mass loss. |
| Substantial Equivalency: | The Sharpoint® PDO sutures are equivalent to thepredicate device PDS II in material composition,intended use, absorption profile and bench testing. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Surgical Specialties Corporation dba Angiotech % Ms. Elizabeth Lazaro Regulatory Affairs Specialist 100 Dennis Drive Reading, Pennsylvania 19606
MAY - 9 2007
Re: K063680
Trade/Device Name: Sharpoint® PDO Sutures Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: April 19, 2007 Received: April 20, 2007
Dear Ms. Lazaro:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Elizabeth Lazaro
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Fa
Mark N. Melkerson
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Sharpoint® PDO Sutures
Indications For Use;
Sharpoint® PDO sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular, or neurological tissues, microsurgery or ophthalmic surgery.
| Prescription Use(Part 21 CFR 801 Subpart D) | ✓ |
|---|---|
| AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| I063680 | Page 1 of 1 | |
|---|---|---|
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raders 4 los and and and and and and on the collection of the comments of the comments of the comment
.......
§ 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.