(81 days)
K# 914220, K# 91424
Not Found
No
The device description and other sections do not mention any AI or ML technologies. The device is described as a simple suction pump with a foot-operated switch and adjustable vacuum pressure.
No
The device is described as a suction pump that provides low-flow regulated negative pressure for general suction and aspiration, which is a supportive rather than a directly therapeutic function.
No
Explanation: The device is described as providing regulated negative pressure for general suction and aspiration, which are therapeutic or assistive functions during procedures, not diagnostic ones. It does not analyze data or provide information about a patient's medical condition.
No
The device description explicitly details hardware components such as a diaphragm pump, mains voltage supply, overflow bottle, and a foot-operated switch with an air-operated solenoid. This indicates it is a physical medical device with integrated hardware, not a software-only 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 "Provide Low flow regulated negative pressure for general suction and aspiration." This describes a physical process performed on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description details a vacuum pump, foot switch, overflow bottle, and diaphragm pump. These are components of a medical device used for suction, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
In summary, this device is a medical device used for suction and aspiration during surgical procedures, which falls under the category of general medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Provide Low flow regulated negative pressure for general suction and aspiration.
Product codes (comma separated list FDA assigned to the subject device)
ICX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K# 914220, K# 91424
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.1850 Dye and chemical solution stains.
(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.
0
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.
1
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:
2
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
3
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)