(78 days)
No
The summary describes a surgical suture and its intended use, with no mention of AI or ML technology. The performance studies focus on compliance with USP requirements for sutures.
No
The device is a surgical suture used for tissue approximation and ligation, which are procedures rather than direct therapeutic treatments.
No
Explanation: The device, CP-Fiber, is described as a synthetic non-absorbable suture used for soft tissue approximation and/or ligation in surgeries. Its intended use is therapeutic (repair/joining tissue) rather than diagnostic (detecting, monitoring, or predicting disease).
No
The device description clearly states that CP-Fiber is a "synthetic non-absorbable suture composed of a braided polyblend," which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of CP-Fiber is for "soft tissue approximation and/or ligation" during surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: It is described as a "synthetic non-absorbable suture." Sutures are used to physically close wounds or tie off vessels during surgery.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition. This is the core function of an IVD.
IVDs are devices used in vitro (outside the body) to examine specimens from the human body to provide diagnostic information. CP-Fiber is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.
Product codes
GAT
Device Description
CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue approximation and/or ligation (including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries).
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
The product is unchanged from the predicate device. Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures.
Key Metrics
Not Found
Predicate Device(s)
K041894 - CP-Fiber (proprietary name OrthoFiber®), K040004 - ORTHOCORD™ Suture, K021434 - Arthrex FiberWire®, K063778 - Force Fiber®
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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 the logo for CP Medical. The logo has the letters CP in a stylized font, with the word "Medical" to the right of the letters. Below the logo is the text "Portland, OR USA".
K094028
pg 1 of 1
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| Device Name: | CP-Fiber (OrthoFiber®) | MAR 18 2010 |
|---|---|---|
| Device Model Number: | "CPF" and "BCPF" series | |
| Common or Usual Name: | Non-Absorbable Suture, Synthetic, Polyblend | |
| Classification Name: | GAT, Non-Absorbable Suture, Synthetic, Polyethylene | |
| Device Classification: | Class II, 21 CFR 878.5000 | |
| Predicate Devices: | K041894 - CP-Fiber (proprietary name OrthoFiber®) | |
| from CP Medical, Inc. | ||
| K040004 - ORTHOCORD™ Suture from Depuy Mitek | ||
| K021434 - Arthrex FiberWire® from Arthrex, Inc. | ||
| K063778 - Force Fiber® from Teleflex, Inc. | ||
| Date: | 12/24/09 |
Manufacturer:
Establishment Registration Number:
Official Contact:
Barbara Keller Horton Director of Quality and Requiatory Affairs CP Medical Phone: 503-232-1555 Fax: 503-230-9993
Intended Use: CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.
CP Medical, Inc. 803 NE 25th Ave.
3032563
Portland, OR 97232 USA
Device Description: CP-Fiber is a synthetic non-absorbable suture composed of a braided polyblend. As with all surgical sutures, CP-Fiber is a single-use device. This submission expands the indications for use to include orthopedic surgeries.
Substantial Equivalence Comparison: CP-Fiber is substantially equivalent in intended use and device characteristics to products already on the market in the same product category.
Technological Characteristics: The product is unchanged from the predicate device. Testing activities demonstrate that the product complies with USP requirements for nonabsorbable sutures.
Conclusion: This submission demonstrates that CP-Fiber is substantially equivalent to the identified predicate devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
CP Medical, Inc % Ms. Barbara Keller Horton Director of Quality and Regulatory Affairs 803 NE 25th Avenue Portland, Oregon 97232
MAR 1 8 2010
Re: K094028
Trade/Device Name: CP-Fiber Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: March 31, 2010 Received: April 12, 2010
Dear Ms. Horton:
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. Ilsting 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 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); good manufacturing practice requirements as set
2
Page 2 - Ms. Barbara Keller Horton
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K094028
pg 1 of 1
INDICATIONS FOR USE
510(K) number (if known):_
Device Name:_CP-Fiber
Indications for Use:
CP-Fiber is indicated for use in soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, neurological, and orthopedic surgeries.
Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
Page 22 of 44
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MKM
(Division Sign-Off)
Division of Surgical, Orthoped
510(k) Number K094028
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