(149 days)
N18331
N18331
No
The 510(k) summary describes a standard surgical suture and needle, with no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on physical and biological properties of the suture.
Yes
The device is a surgical suture used for soft tissue approximation and ligation, which is a therapeutic intervention.
No
The device, Sharpoint® PDO sutures, is indicated for "general soft tissue approximation and/or ligation," which describes a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a surgical suture made of physical material (Polydioxanone) and attached to stainless steel needles, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided information describes a surgical suture, which is a device used within the body for soft tissue approximation and ligation. It is not used to test samples taken from the body.
- Intended Use: The intended use clearly states it's for "general soft tissue approximation and/or ligation," which is a surgical procedure, not a diagnostic test.
The description and intended use of the Sharpoint® PDO suture clearly place it in the category of a surgical implant/device used directly on the patient's body, not for in vitro testing of specimens.
N/A
Intended Use / Indications for Use
The 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.
Product codes
NEW
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
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
Bench testing has demonstrated the device to be safe and effective. Its performance is equivalent to the predicate device, Ethicon PDS II.
Physical testing was performed on PDO (Polydioxanone) Synthetic, Absorbable sutures to USP 29, including Suture Diameter, Suture Attachment, Tensile Strength. Animal testing was performed for conformance to ISO 10993 for Biocompatibility and Implant studies to demonstrate rates of tensile and mass loss.
Key Metrics
Not Found
Predicate Device(s)
N18331
Reference Device(s)
Not Found
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
page 1 of 2
MAY - 9 2007
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SUBSTANTIAL EQUIVALENCY
| Submitter: | Surgical Specialties Corporation dba Angiotech |
|---|---|
| Address: | 100 Dennis Drive |
| Reading, PA 19606 | |
| Telephone: | 610 404 1000, ext. 2231 |
| Contact Person: | Elizabeth Lazaro |
| Regulatory Affairs Specialist | |
| Date Prepared: | December 6, 2006 revised May 07, 2007 |
| Name of Device: | Sharpoint® PDO ( Polydioxanone) Synthetic, |
| Absorbable, Monofilament Sutures | |
| Common / Usual | |
| Classification Name: | Surgical Suture. |
| Absorbable Polydioxanone Surgical Suture. | |
| Regulation Number: | 878.4840 |
| Device Classification: | Class II Device |
| Predicate Device: | Ethicon's PDS II |
| Submission Number N18331 | |
| Device Description | 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 |
1
page 200 2
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)
| Intended Use: | The 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. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | The Polydioxanone material is well characterized
through absorption studies and biocompatibility
studies.
Bench testing has demonstrated the device to be
safe and effective. Its performance is equivalent to
the predicate device, Ethicon PDS II. |
| Performance Data: | Physical testing was performed on PDO
(Polydioxanone) Synthetic, Absorbable sutures to
USP 29, including Suture Diameter,
Suture Attachment, Tensile Strength. Animal
testing was performed for conformance to ISO
10993 for Biocompatibility and Implant studies to
demonstrate rates of tensile and mass loss. |
| Substantial Equivalency: | The Sharpoint® PDO sutures are equivalent to the
predicate device PDS II in material composition,
intended use, absorption profile and bench testing. |
2
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.
3
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
4
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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