(28 days)
Not Found
No
The device description and performance studies focus on mechanical properties and sterilization, with no mention of AI or ML.
No
The device is described as an instrument used to temporarily occlude blood vessels during surgical procedures, which is an operative function, not a therapeutic one. It facilitates a procedure but does not directly treat or cure a disease or condition.
No
Explanation: The device is designed to temporarily occlude blood vessels during surgical procedures, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines a physical medical device consisting of a ring handle, flexible shaft, and jaw, used for occluding blood vessels. It also details material and manufacturing similarities to predicate devices and mentions non-clinical tests related to physical properties like strength and reusability. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "occlude a blood vessel temporarily." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a surgical clamp with a handle, shaft, and jaw. This is a physical tool used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information based on such analysis. The performance studies focus on the physical properties of the clamp (strength, reusability, biocompatibility), not on diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The V. Mueller Cosgrove™ Flex Clamps are indicated to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
Product codes
DXC
Device Description
Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring handle, flexible shaft and jaw. The design of the flexible shaft allows the end user to bend the shaft following clamping of the blood vessel providing the user a clear field of visualization to the surgical site.
The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessel
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
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
- Characteristic: Instrument strength; Standard / Test / FDA Guidance: Strength Tests, Life Cycle Test; Results Summary: PASS
- Characteristic: Device must be reusable; Standard / Test / FDA Guidance: Cleaning and Sterilization Tests; Results Summary: PASS
- Characteristic: Device is able to be cleaned and sterilized; Standard / Test / FDA Guidance: AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ISO 11138, ISO 17664, ISO 17665; Results Summary: PASS
- Characteristic: Device materials are biocompatible; Standard / Test / FDA Guidance: ISO 10993; Results Summary: PASS
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION:
N/A - No clinical tests were conducted for this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
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March 4, 2021
CareFusion 2200, Inc. Jane Weber Regulatory Affairs Sr. Manager 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K210324
Trade/Device Name: V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: February 2, 2021 Received: February 4, 2021
Dear Jane Weber:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210324
Device Name
V. Mueller Cosgrove Flex Clamps
Indications for Use (Describe)
The V. Mueller Cosgrove™ Flex Clamps are indicated to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY – K210324
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion 2200 Inc. |
| Address | 75 North Fairway Drive |
| Vernon Hills, IL 60061 | |
| Phone number | (847) 362-8094 |
| Establishment Registration | |
| Number | 1423507 |
| Name of contact person | Jane Weber |
| Date prepared | March 4, 2021 |
| DEVICE INFORMATION | |
| Trade or proprietary name | V. Mueller Cosgrove™ Flex Clamp |
| Common or usual name | Vascular Clamp |
| Classification name | Vascular Clamp |
| Classification panel | 74 Cardiovascular |
| Regulation | Class II per 21CFR 870.4450, Product code DXC |
| Product Code(s) | CV1033, CV1061, CV1133, CV1161, CV1186 |
| Legally marketed device(s) to | |
| which equivalence is claimed | Cosgrove Flex Clamp - K974769 |
| Cosgrove Flex Clamp Quick-Bend™ - K991589 | |
| Reason for 510(k) submission | Design and labeling modifications |
| Device description | Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring |
| handle, flexible shaft and jaw. The design of the flexible shaft | |
| allows the end user to bend the shaft following clamping of the | |
| blood vessel providing the user a clear field of visualization to the | |
| surgical site. |
The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness. |
| Intended use of the device | To be used to occlude a blood vessel temporarily |
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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| Characteristic | Predicate Devices | New Device |
|---|---|---|
| Type of Device | Reusable | Reusable |
| How Supplied | Non-Sterile | Non-Sterile |
| Sterilization Modalities | Pre-vacuum Steam | |
| Gravity Steam | ||
| Ethylene Oxide | Pre-vacuum Steam | |
| Ethylene Oxide | ||
| Insert Jaw Lengths | 33mm, 61mm, 86mm | 33mm, 61mm, 86mm |
| Materials | Stainless Steel | Stainless Steel |
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
| Characteristic | Standard / Test / FDA Guidance | Results Summary |
|---|---|---|
| Instrument strength | Strength Tests, Life Cycle Test | PASS |
| Device must be reusable | Cleaning and Sterilization Tests | PASS |
| Device is able to be cleaned | ||
| and sterilized | AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, | |
| ISO 11138, ISO 17664, ISO 17665 | PASS | |
| Device materials are | ||
| biocompatible | ISO 10993 | PASS |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
The results of the non-clinical tests demonstrate the V. Mueller Cosgrove™ Flex Clamps meet all performance requirements and are substantially equivalent to the predicate devices.