(56 days)
No
The 510(k) summary describes a surgical suture and does not mention any AI or ML components. The device description, intended use, and performance studies are all related to the physical properties and function of the suture.
No
A therapeutic device is one that treats a disease or condition. This device, a suture, is used for soft tissue approximation and/or ligation, which is a supportive rather than therapeutic function.
No
The device, Monoswift™, is a synthetic absorbable suture used for soft tissue approximation and/or ligation. Its function is to hold tissue together, which is a treatment or surgical aid, not a diagnostic process to identify diseases or conditions.
No
The device description clearly states it is a "monofilament, synthetic absorbable suture," which is a physical medical device, not software.
Based on the provided information, the Monoswift™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "soft tissue approximation and/or ligation". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces that it is a "monofilament, synthetic absorbable suture" used for surgical purposes.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The Monoswift™ does not perform this function.
- Performance Studies: The performance study mentioned focuses on "needle attachment tensile strength," which is a physical property relevant to a surgical suture, not an analytical performance metric for an IVD.
Therefore, the Monoswift™ is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Product codes
GAM
Device Description
Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
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
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
CP Medical Visorb, K002190, Ethicon Monocryl, K960053, K964072
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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
K072229 LL
Image /page/0/Picture/1 description: The image shows the logo for CPI Medical. The logo has the letters CPI in a stylized font, with the letters outlined in white and filled with a gray pattern. The word "Medical" is written in a similar font to the right of the letters CPI. Below the logo, the words "Portland, OR USA" are written in a smaller font.
OCT 5" 2007
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| Device Name: | Monoswift™ Synthetic Absorbable Suture |
|---|---|
| Device Model Number: | "Lxxx" series |
| Classification Name: | Absorbable Suture, Synthetic, Polyglycolic Acid (GAM) |
| Device Classification: | Class II, 21 CFR 878.4493 |
| Predicate Devices: | CP Medical Visorb, K002190 |
| Ethicon Monocryl, K960053 (dyed) , K964072 (undyed) | |
| Manufacturer: | CP Medical |
| 803 NE 25th Ave. | |
| Portland, OR 97232 USA | |
| Establishment | |
| Registration Number: | 3032563 |
| Official Contact: | Betsy Cortelloni |
| Regulatory Affairs Manager | |
| Theragenics Corporation® | |
| 5203 Bristol Industrial Way | |
| Buford, GA 30518 | |
| Phone: 770-271-0233 | |
| Fax: 770-831-4369 |
Intended Use: Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Device Description: Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Substantial Equivalence Comparison: Monoswift™ performance for the intended use is similar to that of other PGCL sutures in that it is a monofilament, synthetic absorbable surgical suture comprised of poly(glycolic co-caprolactone) and may be dyed with D&C Violet #2. Breaking strength retention is consistent with the predicate PGCL sutures.
Design Verification: The testing and verification activities performed for this product demonstrate that the product complies with USP requirements for needle attachment tensile strength.
Conclusion: The results of verification testing confirmed that design inputs were achieved and that Monoswift™ is substantial equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CP Medical % Theragenics Corporation Ms. Betsy Cortelloni Regulatory Affairs Manager 5203 Bristol Industrial Way Buford, Georgia 30518
OCT 5 2007
Re: K072229
Trade/Device Name: Monoswift" Synthetic Absorbable Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly (glycolide/L-lactide) surgical suture Regulatory Class: II Product Code: GAM Dated: August 9, 2007 Received: August 10, 2007
Dear Ms. Cortelloni:
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
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Page 2 - Ms. Betsy Cortelloni
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. 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,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 3 – Ms. Betsy Cortelloni
cc: HFZ-401 DMC HFZ-404 510(k) Staff
HFZ-410 Division D.O. f/t:NOH:kxl:10-03-07
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
. . . . . . . . .
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and the control of the county of
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INDICATIONS FOR USE FORM
510(K) number (if known):_____________________________________________________________________________________________________________________________________________________ K072229
Device Name: MonoSwift™
Indications for Use:
Monoswift™ is a monofilament, synthetic absorbable suture indicated for use in soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological surgery, microsurgery, or ophthalmic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Murla A. Wilkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number