(91 days)
The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.
The VASOSHIELD Pressure Controlling Syringe is identical to the InPress Syringe in design, materials, principles of operation, and manufacturing process. The syringe is comprised of 10 biocompatible components including a syringe, a syringe stopper, ball, stainless steel pin, spring and rod, green acetal ring, black acetal pusher, a white acetal knob and body. The syringe has three predetermined pressure settings of 150 mm Hg, 250 mm Hg, and 350 mm Hg. The syringe is a single use device, supplied sterile.
The provided 510(k) summary for the VASOSHIELD Pressure Controlling Syringe (K082725) states that performance data was reviewed and demonstrated that the device "meets the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the document does not provide explicit details on the specific acceptance criteria or the study that generated the performance data.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what information can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document only broadly states "meets the established acceptance criteria." | "performs in a manner equivalent to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a medical instrument (syringe), not an AI/diagnostic software that requires expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical instrument, not an AI/diagnostic software.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical instrument, not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical instrument, not an AI/diagnostic software. The performance data would likely relate to the mechanical and functional properties of the syringe (e.g., pressure control accuracy, sterility, material biocompatibility, and durability).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated. For a device like this, ground truth would typically refer to established engineering specifications, industry standards, or performance benchmarks related to pressure accuracy, material strength, sterility, etc. The document mentions "equivalent to the predicate devices," suggesting the predicate devices' established performance serves as a benchmark.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device, not an AI algorithm.
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Kof2725
510(k) SUMMARY
| DEC 17 2008 | |
|---|---|
| Submitter | MAQUET Cardiovascular |
| Submitter'sAddress | 170 Baytech RoadSan Jose, CA 95134 |
| Telephone | (408) 635-6824 |
| Fax | (408) 635-3907 |
| Contact Person | Christina L. Rowe |
| Date Prepared | September 16, 2008 |
| Device TradeName | VASOSHIELD Pressure Controlling Syringe |
| DeviceCommon Name | Distention and irrigation syringe |
| DeviceClassificationName | Introduction/drainage catheter and accessories |
| DeviceClassification | Class II |
| Summary ofsubstantialequivalence | The design, materials, method of delivery, features, and intended use of theVASOSHIELD Pressure Controlling Syringe are substantially equivalent to thepredicate devices: InPress Syringe, (K043515, cleared on March 31, 2005), theDMC Saphenous Vein System (K000704, cleared on May 19, 2000), and theDLP Pressure Sensing Syringe (K853586, cleared on November 14, 1985). |
| Devicedescription | The VASOSHIELD Pressure Controlling Syringe is identical to the InPressSyringe in design, materials, principles of operation, and manufacturing process.The syringe is comprised of 10 biocompatible components including a syringe, asyringe stopper, ball, stainless steel pin, spring and rod, green acetal ring, blackacetal pusher, a white acetal knob and body. The syringe has threepredetermined pressure settings of 150 mm Hg, 250 mm Hg, and 350 mm Hg.The syringe is a single use device, supplied sterile. |
| Indications forUse | The device is indicated for controlling pressure during the preparation andirrigation of bypass grafts prior to use in bypass surgery. |
| Technologicalcharacteristics | The VASOSHIELD Pressure Controlling Syringe is identical to the InPressSyringe and features similar fundamental scientific technology as its otherpredicate devices. |
| Performancedata | The results of testing and data review demonstrate that the VASOSHIELDPressure Controlling Syringe meets the established acceptance criteria andperforms in a manner equivalent to the predicate devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The eagle is black, and the text is in a simple, sans-serif font. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2008
Maquet Cardiovascular, LLC. c/o Ms. Christina L. Rowe Principal Regulatory Affairs Associate 170 Baytech Drive San Jose, CA 95134
Re: K082725
VASOSHIELD Pressure Controlling Syringe Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: Class II (two) Product Code: GBX Dated: September 16, 2008 Received: September 25, 2008
Dear Ms. Rowe:
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.
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Page 2 - Ms. Christina L. Rowe
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 l'ederal 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. 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) 276-0120. 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,
$\gamma$
Bram D. Zickerman, 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 STATEMENT
| 510(k) number (if known) | K082725 |
|---|---|
| Device name | VASOSHIELD Pressure Controlling Syringe |
| Indications for Use | The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery. |
Prescription Use _ X (21 CFR 801 Subpart D) 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)
(Division Sign-Off)
Division of Cardiovascular Devises 510(k) Number 0 X
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.