(81 days)
Provide Low flow regulated negative pressure for general suction and aspiration.
The Craft™ Suction Pumps have been developed to provide a smooth low volume vacuum at variable negative pressure. The device has the same technological characteristics as the predicate device. vacuum being activated by a foot operatual switch controlled by the surgeon. The range of vacuyum being variable from 0-4.50mmHg and adjustable over this range by a pre-set control. Vacuum is provided by a quiet diaphringm pump, working from a mains voltage supply (USA I IOV 60Hz). An overflow bottle provides a mensure of safety to prevent aspirated fluids being drawn into the vacuum power unit. The tran also acting us a reservoir to provide an even vacuum pressure during procedures, The foot control has an air-operated solennid, switching the main purnp unit. No electrical connections are made to the sealed foot operated control.
The provided text is a 510(k) summary for a medical device submitted to the FDA in 1997. It describes a "Craft™ Suction Pump" and "Craft™ Duo-Vac Suction Pump" by Rocket Medical plc.
Based on the provided text, a detailed answer to your request regarding acceptance criteria and study information is not available. The document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a performance study with detailed acceptance criteria and results.
Here's a breakdown of what can and cannot be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not available in the provided text. The document states, "The device is indicated for use to provide low flow regulated negative pressure for general suction and aspiration. These devices are safe and effective for the above application and have been tested to confirm there safety and effectiveness in this format for over 12 years, without incident in the UK." This is a general statement about safety and effectiveness, but it doesn't specify quantitative acceptance criteria (e.g., specific vacuum levels, flow rates with tolerances) or provide measured performance data from a formal study.
2. Sample Size Used for the Test Set and Data Provenance:
- Not available. The document mentions "tested to confirm there safety and effectiveness in this format for over 12 years, without incident in the UK." This implies historical data or market experience, but not a specific test set with a defined sample size or detailed provenance. It's likely referencing post-market surveillance or general clinical use over time.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not available. There is no mention of a test set with an established ground truth using experts in this document. Substantial equivalence claims typically rely on comparing device specifications and indications for use to a legally marketed predicate device, rather than on expert-adjudicated test sets for performance.
4. Adjudication Method for the Test Set:
- Not applicable/Not available. As there's no mention of a test set requiring ground truth establishment, no adjudication method is discussed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, not performed according to the document. This type of study would compare human reader performance with and without AI assistance, which is not relevant for a suction pump device or the regulatory pathway taken (510(k) for substantial equivalence based on existing predicate).
6. Standalone (Algorithm Only) Performance Study:
- No, not applicable. This device is a physical medical device (suction pump), not an algorithm or AI system. Therefore, a standalone algorithm performance study would not be relevant.
7. Type of Ground Truth Used:
- Not applicable in the context of a formal performance study for this submission. The "ground truth" for this 510(k) submission is the demonstration of substantial equivalence to predicate devices, supported by the device's design, materials, and intended use being similar to those already on the market. The claim of "tested to confirm their safety and effectiveness... for over 12 years, without incident in the UK" suggests real-world performance as an anecdotal "ground truth" for safety and effectiveness, but not a formally established ground truth for a specific test set.
8. Sample Size for the Training Set:
- Not applicable/Not available. As this is a physical medical device and not an AI/ML product, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary, the provided document is a regulatory submission for a physical medical device (suction pump) aiming for 510(k) clearance based on substantial equivalence. It does not provide the detailed study results, acceptance criteria, or ground truth information typically associated with performance studies for certain types of medical devices (e.g., diagnostic imaging, AI/ML products). The "testing" mentioned refers to general safety and effectiveness observed over years in the UK, rather than a specific, controlled study with defined metrics.
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P-02
K972867
Rocket Medical plc - 510(k) Notification Craft™ Suction Units
OCT 2 4 1997
Summary of Safety and Effectiveness
Craft™ Suction Pump Craft™ Duo-Vac Suction Pump
In the Code of Foderil Regulations, relative to the medical devices reviewed by the General and Plastic Surgery devices classification panel, FDA identified Powered suction pumps as a Class II device (878,4780).
These devices, registerval by Rocket Medical plc (Establishment number: 8010022/9610632) are substantially equivalent to devices which are currently in commerce and have been submitted to the FDA and found to be substantially oquivalent. One such device is the Pionext Pro-Pump (K# 914220) and the Pioneer Pro-Punus Dual Control (K# 91424), both found substantially cquivalent 920304, produced by Pionecr Medical Inc., 34 Laurelcrest Road, Madison, CT 06443, USA.
The device is indicated for use to provide low flow regulated negative pressure for general suction and aspiration. These devices are safe and effective for the above application and have been tested to confirm there safety and effectivencss in this format for over 12 years, without incident in the UK.
The Craft™ Suction Pumps have been developed to provide a smooth low volume vacuum at variable negative pressure. The device has the same technological characteristics as the predicate device. vacuum being activated by a foot operatual switch controlled by the surgeon. The range of vacuyum being variable from 0-4.50mmHg and adjustable over this range by a pre-set control. Vacuum is provided by a quiet diaphringm pump, working from a mains voltage supply (USA I IOV 60Hz). An overflow bottle provides a mensure of safety to prevent aspirated fluids being drawn into the vacuum power unit. The tran also acting us a reservoir to provide an even vacuum pressure during procedures, The foot control has an air-operated solennid, switching the main purnp unit. No electrical connections are made to the sealed foot operated control.
Rocket Medical plc continues to search all appropriate sources for information relating to safety and effectiveness and maintains an in-house reporting system to identify adverse safety and effectiveness information and as such, applicable data is recorded for this product.
CERTIFICATION
I hereby certify that this Summary of Safety and Effectiveness applies for the above indicated devices.
Z.G. Zill
Signed by Leslic Todd Quality Assurance and Regulatory Affairs Manager Rocket Modical plc Wear Industrial Estate, Washington Tyne & Wear. England. NE37 INE Tel: 011 44 191 416 6776
21st October 1997
Image /page/0/Picture/16 description: The image shows the logo for Rocketmedical. The logo consists of a black circle with a white design inside, and the word "Rocketmedical" is written in a stylized font below the circle. The font is black and appears to be slightly italicized.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT 2 4 1997
Mr. L. Todd Mr. D. Todd
Quality Assurance & Regulatory Affairs Manager Rocket Medical PLC Wear Industries Estate Washington Tyne & Wear NE37 1NE United Kingdom
K972867 Re : Craft Duo-Vac Suction Unit, Craft Suction Trade Name: Unit Requlatory Class: II Product Code: ICX Dated: July 11, 1997 August 4, 1997 Received:
Dear Mr. Todd:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Todd
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Rocket Medical plc - 510(k) Notification Craft™ Suction Units
Page 1 of 1
Device Name: Craft™ Suction Pump and Craft™ Duo-Vac Suction Pumps
Indications for Use:
A vacuum powered body fluid suction apparatus could be used in a variety of clinical conditions, however , these particular units have been developed to:
Provide Low flow regulated negative pressure for general suction and aspiration.
Signature
Signed L. Todd QA and Regulatory Affairs Manager Rocket Medical Plc
11th July 1997
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, Office of Device Evaluation (ODE)
Patricia Crescenti
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972847
6 Prescription use_
OR
Over-The -Counter Use ________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 864.1850 Dye and chemical solution stains.
Link to an amendment published at 90 FR 55981, Dec. 4, 2025. (a)
Identification. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.(b)
Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9. These devices are also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.