(46 days)
PDS II
None
No
The 510(k) summary describes a surgical suture and does not mention any AI or ML technology.
No
A therapeutic device is used to treat a disease, condition, or injury. Sutures are used to approximate tissue and are not considered a therapeutic device.
No
The provided text describes a monofilament synthetic absorbable suture used for tissue approximation, which is a therapeutic rather than a diagnostic function.
No
The 510(k) summary describes a physical medical device (absorbable sutures) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical suture used for soft tissue approximation. This is a medical device used in vivo (within the body) during a surgical procedure.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not fit that description.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, Mono-Dox, Monofilament Synthetic Absorbable Sutures are a surgical medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Mono-Dox, Monofilament Absorbable Synthetic Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation. including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Mono-Dox is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
Product codes
GAM, NEW
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
pediatric
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PDS II
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
Image /page/0/Picture/0 description: The image shows a logo for CP Medical in Portland, Oregon. The logo has a black square on the left side with the letters CP in white. To the right of the square, the word "Medical" is written in large, bold, black letters. Below the word "Medical", the words "Portland, Oregon" are written in a smaller, black font.
P.O. BOX 6724 . PORTLAND, OR 97208 . 503- 232-1555 1-800-950-2-63
510(K) SUMMARY
NOV 1 6 2001
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990. 21 CHR 807.92
| Device Name:
| Trade Name: | Mono-Dox. Synthetic Absorbable Suture, Sterile | |
|---|---|---|
| Common Name(s): | Suture Synthetic Absorbable Surgical, Polydioxanone | |
| Classification Name(s): | Suture, Absorbable. Synthetic, Polyglycolic Acid | |
| Name: | C.P. Medical, Inc. | |
| 836 N.E. 24th. Ave | ||
| Portland, Oregon 97232 | ||
| Tele: (503) 232-1555 | ||
| Fax: (503) 230-9993 | ||
| FDA REG.No. 3032563 | Establishment Name, Contact & Registration Number: |
Contact:
Classification:
Class II Device Class: Classification Panel: General & Plastic Surgery Product Code: GAM
Mary Ann Greenawalt (Director of Regulatory)
Intended Use:
Mono-Dox, Monofilament Absorbable Synthetic Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation. including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Mono-Dox is not indicated for use in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
Equivalent Predicated Device:
C.P. Medical believes that the Mono-Dox. Absorbable Synthetic (Polydioxanone) Suture is substantially equivalent to the following absorbable suture marketed by Ethicon. Inc.:
PDS II, Synthetic Absorbable Polydioxanone Surgical Sutures
With respect to substantial equivalence, the comparison device represents a virtually identical device. Materials, packaging, sterilization methods, sizes multi- and monofilament, dyed and undyed as well as functional characteristics (absorption rate, strength, etc.). Equivalency can also be drawn with respect to the design, material composition, performance and intended use. Mono-Dox and PDS II sutures both meet or exceed the performance requirements (except for diameter) set forth by USP 24.
U.A. Horenaud
Managing Director
Mary Ann Greenawalt. Director Regulatiny and Quality
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mary Ann Greenwalt CP Medical 836 N. E. 24th Avenue Portland, Oregon 97232
Re: K013274
Trade Name: Mono-Dox Synthetic Absorbable PDS Suture Regulation Number: 878.4840 Regulation Name: Polydioxanone Suture Regulatory Class: II Product Code: NEW Dated: September 28, 2001 Received: October 1, 2001
Dear Ms. Greenwalt:
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. Iisting 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.
2
Page 2 - Ms. Mary Ann Greenwalt
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
Image /page/2/Picture/5 description: The image contains a handwritten letter 'P' in cursive. The letter is written in black ink on a white background. The letter is slightly tilted to the left.
Celia M. Witten, Ph.D., MD Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
NOV 1 6 2001
Prescription Use
(per 21 CFR 801.109)
510(k) Number: K01 3274
Page 1 of 1 .
Device Name(s): Mono-Dox™, Synthetic Absorbable Polydioxanone Suture, Sterile
Intended Use(s) of the Device:
Mono-Dox, Monofilament Synthetic Absorbable Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.
Mono-Dox suture is not indicated for use in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are useful where an absorbable suture with extended wound support (up to six weeks) is desirable.
Please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Walk
(Division Sig -- 1ff) Division of Concral, Restorative and Neurologal Devices
510(k) Number: `K013274
or
Over-The-Counter Use --------
(Optional format 1-2-96)