A-V FOOT PUMP

{0}------------------------------------------------ pg 1 of 5 Dalian Labtek Science & Development Co., Ltd. Room 403, No. 35 Huoju Road, High-Tech Zone, Dalian, Liaoning, China 116085 Tel: +86 411 84548445 AUG 1 7 2012 # Section 5 510(k) Summary [As required by 21 CFR 807.92] ## 1. Submission Information: | 510(k) Number: | K121718 | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Date: | May 10th, 2012 | | Type of 510(k) Submission: | Traditional | | Basis for 510(k) Submission: | New device | | Submitter/Manufacturer: | Dalian Labtek Science & Development Co., Ltd.<br>Room 403, No. 35 Huoju Road, High-Tech Zone, Dalian, Liaoning, China | | Contactor: | Doris Dong, Consultant<br>Shanghai CV Technology Co., Ltd.<br>E-mail: doris_d@126.com<br>Tel: 86 21-31261348 / Fax: 86 21-37824346 | ## 2. Device Description: | Proprietary Name: | A-V Hand & Foot Pump, Model LBTK-M-1 1000 | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Intermittent Pneumatic Compression Device | | Classification Name: | Compressible limb sleeve | | Regulation Number: | 21 CFR 870.5800 | | Product Code: | JOW | | Device Class: | II | | Review Panel: | Cardiovascular | | Indications for use: | A-V Hand & Foot Pump, Model LBTK-M-I 1000, is intended for use to<br>enhance blood circulation in the arteries and veins in patents. The indications<br>vary depending on whether pump is used with the foot pad or hand pad.<br>A. Foot use<br>- Acute Edema<br>- Chronic Edema<br>- Circulation Enhancement<br>- Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis<br>- Leg Pain Incident to Trauma or Surgery<br>- Leg Ulcers<br>- Venous Stasis/Venous Insufficiency<br>B. Hand use<br>- Acute Edema<br>- Chronic Edema<br>- Circulation Enhancement<br>- Pain Incident to Trauma or Surgery | | Device Description: | A-V Hand & Foot Pump, Model LBTK-M-I 1000, consists of a pump controller<br>connected by air supply hoses to specially designed inflation pads.<br>The pump controller is microprocessor controlled, with a liquid crystal<br>display, power switch, two air output sockets, function keys of "Left impulse | | Tel: +86 411 84548445 | run/pause", "Pressure adjustment", "Left preset settings", "Increase key-press",<br>"Decrease key-press", "Right preset settings", "Impulse interval control", "Right<br>Impulse run/pause", and so on. The pulse pressure, pulse duration, and pulse<br>interval can be displayed by the screen.<br>The inflation pads include foot pad, hand pad and undercast foot pad. The<br>pads have one air chamber, through which the air energy is transferred to the<br>body. The pads are non-sterile and for single patient use only.<br>The inflation pad is rapidly inflated by a controlled impulse of air from the<br>controller. After each impulse the controller automatically allows the inflation<br>pad to deflate. To deliver the impulse pressure effectively to the extremity, the<br>inflation pad must be retained in the correct position.<br>The system has built-in alarms and displays to alert attention to adjustment<br>requirements and to assist with rapid troubleshooting. | | Specifications: | Power supply: AC110V/0.2A/50-60Hz<br>Length/Height/Width: 365mm/220mm/150mm<br>Weight: 4kg<br>Tubing length: 2m<br>Tubing diameter: OD-8mm, ID-6mm<br>Mode of operation: Rapid inflation and deflation, manual switch<br>Number of channels: 2<br>Number of air chamber: 1<br>Inflation time: 0.2 seconds<br>Impulse duration: 1 or 3 seconds adjustable<br>Pulse interval: 20~50s for inflation foot pads; 12~20s for inflation hand pads<br>Pressure: 60mmHg~200mmHg<br>Inflation Pump Connector Design: Air pump → hoses → air cylinder →<br>magnetic valve → airway tube → pads | | Performance data: | The device has passed the following testing:<br>1) Biological compatibility test<br>2) Material anti-stretch test<br>3) Air chamber welding point anti-stretch test<br>4) Air leakage test<br>5) Air chamber maximum blast pressure test<br>6) Electromagnetic compatibility test | | Standards: | ISO 10993-1: 2009: Evaluation and testing within a risk management process<br>ISO 10993-5: 2009: Tests for cytotoxicity: In vitro methods;<br>ISO 10993-10: 2010: Tests for Irritation and Sensitization;<br>IEC 60601-1: 2005: Medical electrical equipment - Part 1: General requirements<br>for basic safety and essential performance<br>IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: Electromagnetic<br>compatibility Requirements and tests | {1}------------------------------------------------ K121718 pg 2 of 5 Dalian Labtek Science & Development Co., Ltd. Room 403, No. 35 Huoju Road, High-Tech Zone, Dalian, Liaoning, China 116085 Tel: +86 411 84548445 ## 3. Substantial Equivalence: · Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission. {2}------------------------------------------------ | 510(k) Number: | K121718 | K964425 | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code: | JOW | JOW | | Proprietary Name: | A-V Hand & Foot Pump, Model LBTK-M-1 1000 | A-V IMPULSE SYSTEM MODEL 6060 | | Manufacturer: | Dalian Labtek Science & Development Co., Ltd. | NOVAMEDIX SERVICES LTD | | Indications for use: | A. Foot use<br>- Acute Edema<br>- Chronic Edema<br>- Circulation Enhancement<br>- Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis<br>- Leg Pain Incident to Trauma or Surgery<br>- Leg Ulcers<br>- Venous Stasis/Venous Insufficiency<br><br>B. Hand use<br>- Acute Edema<br>- Chronic Edema<br>- Circulation Enhancement<br>- Pain Incident to Trauma or Surgery | For lower extremities:<br>- Acute Edema<br>- Chronic Edema<br>- Circulation Enhancement<br>- Deep Vein Thrombosis Prophylaxis<br>- Leg Pain Incident to Trauma or Surgery<br>- Leg Ulcers<br>- Venous Stasis/Venous Insufficiency<br><br>For upper extremities:<br>- Acute Edema<br>- Chronic Edema<br>- Circulation Enhancement<br>- Pain | | Components: | Pump controller, air supply hoses, inflation pads | Pump controller, air supply hoses, inflation pads | | Working principle: | Imitate natural physiological "foot pump" and "hand pump" to increase the speed of venous return and artery supply | Imitate natural physiological "foot pump" and "hand pump" to increase the speed of venous return and artery supply | | Mode of operation: | Rapid inflation and deflation, manual switch | Rapid inflation and deflation, manual switch | | Maximum number of times Reprocessed: | not reusable or reprocessable | not reusable or reprocessable | | Performance: | | | | - Number of channels: | 2 | 2 | | - Inflation time: | 0.2 seconds | 0.4 seconds | | - Impulse duration: | 1 or 3 seconds adjustable | 1 or 3 seconds adjustable | | - Inflate frequency: | 12-50 seconds | 12-50 seconds | | | | | | Pressure: | 60mmHg~200mmHg | 60mmHg~200mmHg | | Compression cycle time: | 12s~50s adjustable | 12s~50s adjustable | | Specifications: | | | | Length/Height/Width: | 365mm/220mm/150mm | 260mm/162mm/234mm | | Weight: | 4kg | 3.4kg | | Tubing length: | 2mm | 2m | | Power supply: | AC110V/0.2A/50-60Hz | 120V/0.6A/60Hz | | Fuse: | T1Ax20mm(Antisurge) | T1Ax20mm(Antisurge) | | Number of chambers: | 1 | 1 | | Standards: | ISO 10993-5: 2009: Tests for cytotoxicity: In vitro methods;<br>ISO 10993-10: 2010: Tests for Irritation and Sensitization;<br>IEC 60601-1-2:2001 Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance collateral<br>standard: Electromagnetic compatibility Requirements and tests | UL 544: UL Standard for Safety Medical and Dental Equipment | | Validation testing: | 1) Biological compatibility test<br>2) Material anti-stretch test<br>3) Air chamber welding point anti-stretch test<br>4) Air leakage test<br>5) Air chamber maximum blast pressure test<br>6) Electromagnetic compatibility test | The Controller is built and tested toUL544. | | Non-sterile: | Non-sterile | The inflation foot pads are in non-sterile and sterile forms. | | Microprocessor Control? | Yes | Yes | | Differences: | The two devices have different outline dimensions, inflation time, compliant standards, validation tests, and so on. | | | Similarities: | The two devices have same components, working principle, intended use, safety features, and so on. | | | Conclusion: | Since the new device A-V Hand & Foot Pump, Model LBTK-M-1 1000, has same components, working principle, intended use, and safety<br>features with the predicate device, they are substantial equivalent. Any difference in technological characteristics does not raise any new safety<br>and effectiveness issues. The conclusion drawn from the testing is that the device is as safe and effective as the predicate device. | | K121718 M365 {3}------------------------------------------------ Dalian Labtek Science & Development Co., Ltd. Room 403, No. 35 Huoju Road, High-Tech Zone, Dalian, Liaoning, China 11608 16 K121718 pg 4 of 5 {4}------------------------------------------------ ### 4. Safety and Effectiveness of the device: ### A. Safety: A-V Hand & Foot Pump is a non-invasive medical device that applies brief pressure pulses to the palm of the hand or sole of the foot. Rather than altering or manipulating normal body functions, the A-V Hand & Foot Pump seeks to mimic the natural pumping mechanisms that already exist in the venous plexus in the hand and foot. Accordingly, the A-V Hand & Foot Pump is intrinsically safe. Apart from the intrinsic safety of the physiological mechanism of the A-V Hand & Foot Pump, the product's components are designed to minimize potential risks to patients during product use. In particular, the product is equipped with the following safety features: (1) In the event of power failure or malfunction of the generator, the venting valve automatically opens so that any pressure in the pads is released. 2 Audio and visual alarms are activated if inflation pads pressure either exceeds or fails to achieve recommended levels. (3) Relevant contraindications, numerous warning proper use and maintenance, are contained in the instruction manual. 4) The product's labeling indicates that the device is restricted to sale by or on the order of a physician. 5 Software validation and other safety features. #### B. Effectiveness A-V Hand & Foot Pump, Model LBTK-M-I 1000, is similar to the predicate device in intended use and mode of operation. A-V Hand & Foot Pump, Model LBTK-M-1 1000, is a manually operated device and does not raise any new issue of safety and effectiveness. {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 AUG 1 7 2012 Dalian Labtek Science & Development Co., Ltd. c/o Ms. Doris Dong Shanghai CV Information Technology Co., Ltd. Rm 1706 Yuesha Building, No. 128 Songle Rd. Songjiang, Shanghai Re: K121718 Trade/Device Name: A-V Hand & foot Pump, Model LBTK-M-I 1000 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Received: June 11, 2012 ## Dear Ms. Dong: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. {6}------------------------------------------------ ## Page 2 - Ms. Doris Dong 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); 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 vours. .g. Allehen Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ ## Section 4 Indications for Use Statement ## 510(k) Number (if known): K121718 ## Device Name: A-V Hand & Foot Pump. Model LBTK-M-I 1000 . . ### Indications for Use: A-V Hand & Foot Pump, Model LBTK-M-I 1000, is intended for use to enhance blood circulation in the arteries and veins in patents. The indications vary depending on whether pump is used with the foot pad or hand pad. A. Foot use - Acute Edema - Chronic Edema - Circulation Enhancement - Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis - Leg Pain Incident to Trauma or Surgery - Leg Ulcers - Venous Stasis/Venous Insufficiency B. Hand use - Acute Edema - Chronic Edema - Circulation Enhancement - Pain Incident to Trauma or Surgery V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) C.M. Miller Page 1 of 1 - 1 (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K121718 12