(68 days)
INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
The Instrumed Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:
- . Some have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
- Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross – action mechanism to apply tension to the vessel for occlusion.
- The choice of jaw style depends on the surgeon's preference, based on the type and delicacy of ↓ the vessel to be occluded.
The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
Instrumed vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy,
The instruments are offered in non-sterile condition.
This is a 510(k) premarket notification for the Instrumed Vascular Clamp, a reusable surgical instrument. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or quantitative performance metrics are provided in the document for the Instrumed Vascular Clamps. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The reported device performance is qualitative, asserting that the new device is "completely comparable" to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics, sizes and configurations) | "The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices." "Biocompatibility and sterilization studies were successfully completed." "The Instrumed product is similar to the predicate device in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics as well as sizes and configurations." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "non-clinical and bench testing" was conducted. However, it does not specify the sample size used for the test set.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a surgical instrument, the non-clinical and bench testing would generally be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a physical device like a vascular clamp, "ground truth" would likely be established through standardized engineering tests and material analyses, not through expert consensus in the typical sense of image-based or diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation appears to be based on direct testing and comparison to predicate devices' specifications, not on expert adjudication of ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices where human interpretation is a key component, not for surgical instruments like vascular clamps.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of the vascular clamps would be based on:
- Engineering Specifications/Standards: Performance criteria related to material strength, clamping force, corrosion resistance, sterilization effectiveness, and biocompatibility, as defined by relevant industry standards (e.g., ASTM F 899-07 for Stainless Steel).
- Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices.
8. The Sample Size for the Training Set
This information is not provided and is generally not relevant for this type of device submission. There is no "training set" in the context of a physical surgical instrument; it's not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no "training set" for this device.
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510(k) Summary
510(k) Summary as required by section 807.92(c)
date prepared 08/17/2009
Submission Applicant:
INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
OCT 2 3 2009
Establishment Registration Number:
1421101
Official Correspondent:
Mr. Berndt Fetzer INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Phone: 847-908-0292
Trade name:
Instrumed Vascular Clamp
Common name:
Various vascular clamps:
Bulldog Clamps, Vessel Clamps, Microvascular Bulldog Clamps, Ring Handle Bulldog Clamps, Neonatal Vascular Clamp, Pediatric Clamps, Occlusion Clamps, Vascular Clamps, Cardio Clamps, Aorna, Roman, Multi-Purpose Clamps, Blood Vessel Forceps, Anastomosis Clarms, Vena Clamps, Torto Clamps, Torto Plan vascular Clamps, Aortic Aneurysm Clamps, Abdominal Clamps, Profunda Clamps, Shunt Clamps, Aortic Clamps, Patent-Ductus Clamps, Fogarty-Type Clamps, Vascular Forceps, Microvascular Forceps, Minimally Invasive Coronary Systems
Classification name:
Clamp, Vascular (21 CFR 870.4450, Product code DXC)
Regulation Description Vascular Clamp
Substantial Equivalence Claims:
| K072834 | SIBEL SA VASCULAR CLAMP; SURGICAL INSTRUMENTS BELGIUM SAP.D. K973080 Surgical Vascular Clamp, Walter Lorenz Surgical, Inc |
|---|---|
| K992053 | AESCULAP VASCULAR INSTRUMENTSAESCULAP, INC.P.D. Preamendments: Aesculap, Codman, Heartport, V.Mueller, Walter Lorenz |
| K070661 | VITALCOR FEATHERWEIGHT VASCULAR CLAMPS; VITALCOR, INC.P.D. K022754 S&T SINGLE USE MICRO ANASTOMOSIS CLAMP; S & T AG |
| K982278 | MICRINS MICRO ANASTOMOSIS CLAMP; MICRINS SURGICAL INC |
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Description of the Device:
The Instrumed Vascular Clamps are reusable surgical instruments. To ensure the multi-purpose use of this device, many different models are available. The differences can be as follows:
- . Some have ring handles with a ratchet closure to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
- Bulldog style Vascular Clamps are another type of vascular cross clamp that use a spring or cross � action mechanism to apply tension to the vessel for occlusion.
- The choice of jaw style depends on the surgeon's preference, based on the type and delicacy of ↓ the vessel to be occluded.
The surgeon chooses the vascular clamp based on the anatomy of the site and the type of occlusion desired, based on the type and size of the blood vessels, and surgical techniques. Clamps are either fully or partially occluding an artery or vein with correct tension to produce minimal trauma to vessels. Full occlusion clamps stops blood flow entirely by covering the full vessel. Partial occlusion clamps are placed on part of the vessel to isolate the area to be worked on while allowing blood flow to continue in the rest of the vessel.
Instrumed vascular clamps are made of the following standardized materials Stainless Steel ASTM F 899-07 or Titanium Alloy,
The instruments are offered in non-sterile condition.
Indications for Use:
INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
Comparison with Predicate Device:
The results of non-clinical and bench testing indicates that the new device is completely comparable to the predicate devices. Biocompatibility and sterilization studies were successfully completed.
The Instrumed product is similiar to the predicate device in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics as well as sizes and configurations. Therefore it can be deemed substantially equivalent for its indicated use.
Conclusion:
The presented data that was conducted on the Instrumed Vascular Clamps shows in its results and in comparison to the predicate devices that the products are substantially equivalent to the predicate devices.
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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, there is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 2 0 2009
Intrumed International, Inc. Michael Massong RA/QA Director 626 Cooper Court Schaumburg, IL 60173
Re: K092544
Trade/Device Name: Intrumed Vascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: September 30, 2009 Received: October 1, 2009
Dear Mr. Massong:
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 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
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Page 2 - Mr. Massong
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Duna R. Vuchner
Image /page/3/Picture/7 description: The image shows a handwritten letter 'f' in a simple, slightly stylized font. The letter is in black ink and appears to be part of a larger text or word. The stroke of the 'f' is continuous, with a curved top and a descending stem.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K092544
Device Name:
Instrumed Vascular Clamps
Indications For Use:
INSTRUMED Vascular Clamps are devices intended for temporary or partial occlusion of blood vessels during vascular surgical procedures.
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)
Duma R. Vc. Amez
Division Sign-C Division of Cardiovascular Devices
10(k) Number_K0925A4
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§ 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).