GENADYNE A4 POWERED SUCTION PUMP

{0}------------------------------------------------ K080745 P. 1 of 7 JUL 30 2008 ### 510k Summary ### General Information Genadyne Biotechnologies Inc. 1. Applicant: 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com 2. Contact Person: Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 Tel: 516-487-8787 Fax: 516-487-7878 andrew@genadyne.com ## 3. Trade/Proprietary Name Including Model Number of Device: Genadyne A4 Powered Suction Pump ### 4. Common Name or Classification Name (21 CFR Part 807.87) of Device: Powered Suction Pump (21 CFR 878.4780, Product Code BTA) ### 5. Class in which Device has been placed: Class II ### 6. Reason for Premarket Notification: Introduction of a new device that is substantially equivalent to a legally marketed device. ## 7. Identification of Legally Marketed Device Which We Claim Substantial Equivalence (Predicate Device): Penumbra Aspiration Pump, K051758 (Aug 16, 2005) {1}------------------------------------------------ ## 8. Compliance with Requirements of the Federal FD&C Act: The General and Restorative Device Panel (DGRD) has classified this device as: Class II 21 CFR 878.4780 Product Code: BTA ## 9. Kit Certification and Information: This device does not contain a kit. ## 10. Description of the Device The Genadyne A4 powered suction pump is a portable suction device that is intended for general suction use in hospitals or clinics. The Genadyne A4 comes with a canister and a power adapter to charge the battery. ## 11. Intended use of the Device Genadyne A4 Powered Suction Pump is intended for general suction use in hospitals or clinics. ### 12. Substantial Equivalence In establishing substantial equivalence to the predicate device, Genadyne Biotechnologies evaluated the indications for use, material, technology, product specifications, and energy requirements of the system. Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4 Powered Suction Pump for the intended use. ### 13. Summary of Safety and Effectiveness Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use. {2}------------------------------------------------ # 14. Comparison to Predicate Device # Table of Comparison to Legally Marketed Device: | Comparative Information | | | |--------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------| | | New Device | Predicate Device<br>(As per AI Letter) | | Company | Genadyne Biotechnologies | Penumbra Inc. | | Device Name | A4 | Penumbra Aspiration Pump | | 510 (K) Number | K080745 | K051758 | | Technical Data | | | | Suction Capacity | 5 liters /minute | 0-30 LPM | | Max Vacuum | 230 mmHg | 635 mmHg (25 inHg) | | Power Requirements | 24 VDC, 1A | 115 V AC, 60 Hz | | Battery Type | Ni-MH | N/A | | Dimensions and<br>Weight | 200 x 180 x 80 mm / 1.36 Kg | 317.5 x 254 x 241.3 mm / 6.58 Kg | | Accessories | | | | Canisters | 800 ml disposable canister with<br>a build-in hydrophobic shut off<br>filter for overflow protection | 1500 ml disposable canister with an<br>external hydrophobic filter | | Reusable | Yes | Yes | | Sterile | Non Sterile | Non Sterile | | Accessory Kit | N/A | N/A | {3}------------------------------------------------ | Indications for Use | The Genadyne A4 is intended<br>for general suction use in<br>hospitals or clinics. | The Asipiration Pump is<br>intended for general suction use<br>in hospitals or clinics. | |---------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------| | Contraindications | N/A | N/A | | Certification | UL 60601-1<br>CAN/CSA C22.2 No. 601-1-<br>M90 | CE0050 | | Storage / Transport | -18°C to +43°C (0°F to 110°F)<br>Relative Humidity 10% to 95 %<br>700 - 1060 mbar Atmospheric<br>pressure | - | | Operation | 18°C to 34°C (65°F to 94°F)<br>Relative Humidity 10% to 95 %<br>700 - 1060 mbar Atmospheric<br>pressure | - | | Testing | IEC 60601-1-2<br>FCC part 15 Class B<br>EN 55011<br>IEC 61000-4-2<br>IEC 61000-4-3 | - | ## 15. Comparative Performance Evaluation: The FDA Decision Tree for substantial equivalence was followed and the steps involved have been considered. The rationale for each step is discussed below. For reviewer convenience, the numbering system used by FDA on the decision tree has been followed by Genadyne in their process for the substantial equivalence determination rationale. {4}------------------------------------------------ K080745 P. 5 of 7 Image /page/4/Figure/1 description: This image is a flowchart titled "510(k) 'SUBSTANTIAL EQUIVALENCE' DECISION-MAKING PROCESS". The flowchart begins with the question, "New Device is Compared to Marketed Device?" and proceeds through a series of questions and decision points. The flowchart is designed to determine whether a new medical device is substantially equivalent to an existing device on the market. Sidella Submitter compare and terreas to mosteles dersea. FDA register sittings in the substitution is the substant + 30 彩 The stacked is nonally bared as descriptive luformation since, but linemation in consistent regulad. ﺔ ﺗﺒﺎﺭﻳﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﻊ ﻓﻲ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗ Data maybe in the SUSE), online 1990)s, the Conses's classification alwa, ar the linersons {5}------------------------------------------------ K080745 P. 6 of 7 ### 16. Discussion of Substantial Equivalence: Note 1: Does new device have same indication statement as the predicate device(s)? Yes. The Genadyne A4 Powered Suction Pump and the Penumbra Aspiration Pump are both intended for general suction use in hospitals or clinics. Note 3: Does the device have the same technological characteristics, e.g., design, materials, etc.? Yes. The Genadyne A4 Powered Suction Pump is design with a suction pump, can be externally and internally powered and has a collection canister, same as the Penumbra Aspiration pump, which also features a suction pump, a collection canister and can be powered externally. Note 5: Are the descriptive characteristics precise enough to ensure equivalence? Yes. The characteristics of the Genadyne A4 Powered Suction Pump and the Penumbra Aspiration pump are precise enough to ensure equivalence, based on the table in item 14 in the 510K Summary. ### 17. Discussion of Similarities and Differences ### Device Similarities #### Indication for use The indication for use is identical for the Genadyne A4 Powered Suction Pump and the predicate device. ### Configuration All devices are sold non-sterile and are intended to be reusable. Devices are compatible with off-the-shelf accessories, such as disposable 1200ml or 1500 ml canisters. ### Basic Product Function The Genadyne A4 Powered Suction Pump and the predicate device have the same product function of generating a vacuum to provide general use suction and collection of liquids into an off-the-shelf canister reservoir. {6}------------------------------------------------ ## Device Differences In comparison to the predicate devices, the Genadyne A4 Powered Suction Pump has several differences which do not affect the device safety and effectiveness of the Genadyne A4 Powered Suction Pump. These differences between the Genadyne A4 Powered Suction Pump and the predicate device are described in further detail below. ## Penumbra Aspiration Pump The only differences between the Genadyne A4 Powered Suction Pump and the Penumbra Aspiration Pump are Genadyne A4 Powered Suction Pump is powered from an adapter and can be battery powered, where as the predicate device can only be powered by plugging into an AC power source. In all other aspects, the Genadyne A4 powered suction pump and the predicate device is substantially equivalent. ## 18. Conclusions: Genadyne believes the Genadyne A4 Powered Suction Pump is substantially equivalent to the predicate device. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 is a stylized representation of an eagle, with three curved lines forming its body and wings. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Genadyne Biotechnologies, Inc. % mdi Consultants, Inc. Mr. John Pappan, M.S. 55 Northern Boulevard, Suit 200 Great Neck, New York 11021 JUL 30 2008 Re: K080745 Trade/Device Name: Genadyne A4 Powered Suction Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: July 25, 2008 Received: July 28, 2008 Dear Mr. Pappan: 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. 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); 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. {8}------------------------------------------------ Page 2 -- Mr. John Pappan, M.S. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Mark M. Mullison - Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Genadyne A4 Powered Suction Pump Indications for Use: The Genadyne A4 Powered Suction Pump is intended for general suction use in hospitals or clinics. AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mark A. Millman (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K08