INTERMITTENT PNEUMATIC COMPRESSION DEVICE

{0}------------------------------------------------ Dalian Labtek Science & Development Co., Ltd. 2-2-2-2, No.4 Zhengren Street, Shahekou District, Dalian, China 116021 #### Section 5 ## 510(k) Summary [As required by 21 CFR 807.92] #### 1. Submission Information: AUG 1 6 2013 510(k) Number: K123830 June 26th, 2013 Date: Type of 510(k) Submission: Traditional Basis for 510(k) Submission: New device Submitter/Manufacturer: Dalian Labtek Science & Development Co., Ltd. 2-2-2-2, No.4 Zhengren Street, Shahekou District, Dalian, China 116021 Contactor: Doris Dong, Consultant Shanghai CV Technology Co., Ltd. Room 1706, No. 128 Songle Rd., Songjiang Area, Shanghai, China 201600 E-mail: doris d@126.com / Url: www.ceve.org.cn Tel: 86 21-31261348 / Fax: 86 21-37824346 2. Device Description: Proprietary Name: Veinoflow SCD, Model LBTK-M-I 5001 | 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: | Veinoflow SCD system, Model LBTK-M-I 5001 is a system to prevent<br>DVT (Deep Vein Thrombosis) by improving the blood velocity of patients.<br>LBTK-M-1 5001 is indicated for Circulation Enhancement, Deep Vein<br>Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain<br>Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous<br>Insufficiency. | | Device Description: | 1) Description of the compression system<br>Veinoflow SCD, Model LBTK-M-I 5001, is a pneumatic pump system that<br>supplies compressed air to inflate garments that are attached to a patent's<br>lower limbs. It consists of a pump controller, specially designed inflation<br>and deflation garments for feet and legs, air supply tubes, and power line.<br>The inflation and deflation garments have 3 types: ① thigh-calf garments,<br>② calf garments, and ③ foot cuffs.<br>The system offers sequential inflation and propels the vein blood from<br>limb to heart, therefore enhance the blood circulation. The controller can<br>automatically detect the external garment type, and provides pressure<br>correspondingly. The pressure value and inflatable interval time are preset<br>and adjustable. | The controller has a self test system, when there is any error, it will alarm both in visual and audio. {1}------------------------------------------------ ### 3. Substantial Equivalence: . Detailed comparison data is included in the section 9 of "Substantial Equivalence Discussion" of this 510(k) submission. {2}------------------------------------------------ Dalian Labtek Science & Development Co., Ltd. 2-2-2-2, No.4 Zheneren Street Shahekou District Dalian, China 116021 | | New Device | Predicate Device | |----------------------------------|-------------------------------------------------------------------------------|------------------------------------------------------------------------| | 510(k) Number: | K123830 | K112677 | | Product Code: | JOW | JOW | | Proprietary Name: | Veinoflow SCD, LBTK-M-I 5001 | The Venous Assist System DVT-2600 | | Manufacturer: | Dalian Labtek Science & Development Co., Ltd. | DAESUNG MAREF CO LTD | | Indications for use: | Veinoflow SCD system, Model LBTK-M-I 5001 is a system to prevent DVT | DVT-2600 is a system to prevent DVT (Deep Vein Thrombosis) by | | | (Deep Vein Thrombosis) by improving the blood velocity of patients. | improving the blood velocity of patients. DVT-2600 is indicated for | | | LBTK-M-I 5001 is indicated for Circulation Enhancement, Deep Vein | Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, | | | Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain | Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma | | | Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous | or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency. | | | Insufficiency. | | | Components: | pump controller, multi-cavity thigh-calf garments, calf garments, foot cuffs, | pump controller, multi-cavity thigh-calf garments, calf garments, foot | | | battery, air supply tubes, power line | cuffs, battery, air supply tubes, power line | | Ingress of Water Protection | Ordinary | Ordinary | | Compression Type | Thigh-calf garments & calf garments: Sequential, Gradient | Thigh-calf garments & calf garments: Sequential, Gradient | | | Foot Cuffs: Uniform | Foot Cuffs: Uniform | | Compression time | Single thigh-calf garment: 5.5s Compression | Single thigh-calf garment: 5.5s Compression | | | Dual thigh-calf garments: 11s Compression | Dual thigh-calf garments: 11s Compression | | | Single calf garment: 4s Compression | Single calf garment: 4s Compression | | | Dual calf garments: 8s Compression | Dual calf garments: 8s Compression | | | Single foot cuff: 2.5s Compression | Single foot cuff: 2.5s Compression | | | Dual foot cuffs: 5s Compression | Dual foot cuffs: 5s Compression | | Deflation time | 2~3s | 2~3s | | Default inflatable interval time | 48s | 48s | | Adjustable inflatable interval | 24s, 48s, 60s | 24s, 48s, 60s | | time | | | | Default Pressure | Thigh-calf garments & calf garments: 40 mmHg | Thigh-calf garments & calf garments: 40 mmHg | | | Foot Cuffs: 130 mmHg | Foot Cuffs: 120 mmHg | | Adjustable pressure | Thigh-calf garments & calf garments: 30-60mmHg | Thigh-calf garments & calf garments: 20-60mmHg | : : : . : {3}------------------------------------------------ | Dalian Labtek Science & Development Co., Ltd. | | | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | | 2-2-2-2, No.4 Zhengren Street, Shahekou District, Dalian, China 116021 | | | | Foot Cuffs: 120~140mmHg | Foot Cuffs: 120-140mmHg | | Mode of Operation | Continuous | Continuous | | Application mode | ① Single thigh-calf garment Compression, | ① Single thigh-calf garment Compression; | | | ② Dual thigh-calf garments Compression; | ② Dual thigh-calf garments Compression; | | | ③ Single calf garment Compression; | ③ Single calf garment Compression; | | | ④ Dual calf garments Compression; | ④ Dual calf garments Compression; | | | ⑤ Single Foot cuff Compression; | ⑤ Single Foot cuff Compression; | | | ⑥ Dual Foot cuffs Compression; | ⑥ Dual Foot cuffs Compression; | | | ⑦ Simultaneous single thigh-calf garment and single calf garment | ⑦ Simultaneous single thigh-calf garment and single calf garment | | | Compression | Compression; | | | | ⑧ Simultaneous single foot cuff and single thigh-calf garment | | | | Compression; | | | | ⑨ Simultaneous single foot cuff and single calf garment | | | | Compression | | Bed Hook | Yes | Yes | | Power Cord Storage | Yes | Yes | | Audible/Visual Alarms | No garment, Pump Error, Valve Error, Temperature Error, Software Error,<br>System Error, High Pressure, Low Pressure, Low Battery | Cuff connection Error, Pressure Error, System Error, Power Error | | Controller Dimensions | Length: 240mm; Width: 140mm; Height: 263mm | Length: 205mm; Width: 155mm; Height: 195mm | | Controller Weight | 3.5kg | 1.9kg | | Power Requirement | AC 100-240V, 50VA, 50/60 Hz | AC 100-240V, 35VA, 50/60 Hz | | Battery | 14.8V, 3100mAhr, Lithium Ion (Optional) | 11.1V, 2500mAhr, Lithium Ion (Optional) | | | Run Time: 3-4 hours | Run Time: 6-8 hours | | | Charge Time: 4~5 hours (charging only) | Charge Time: 4 hours (charging only) | | Shoulder Strap | Yes (optional) | Yes | | Shipping Unit | Each | Each | | Standards: | ISO 10993-1, ISO 10993-5, ISO 10993-10,<br>IEC 60601-1, and IEC 60601-1-2 | ISO 10993-1, ISO 10993-5, ISO 10993-10,<br>IEC 60601-1, and IEC 60601-1-2 | ・ 4-6 : . {4}------------------------------------------------ Dalian Labtek Science & Development Co., Ltd. . | 2-2-2-2, No 4 Zhengren Street, Shahekou District, Dalian, China 116021 | 2) Electromagnetic compatibility test | | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | 3) Anti-stretch test of garment materials | 3) Electrical Safety test | | | 4) Anti-stretch test of air chamber welding point | | | | 5) Air leakage test; 6) Burst testing of garment; 7) Bladder fatiguing test; | | | | 8) Velcro adhesion evaluation test; 9) Biological compatibility test; | | | | 10) Electromagnetic compatibility test; 11) Electrical Safety test | | | | Non-sterile: | Non-sterile | Non-sterile | | Microprocessor Control? | Yes | Yes | | Differences: | The new device and the predicate device have different Audible/Visual Alarms, dimensions and weight, battery capacity, and LCD display panel. The<br>new device has more safety testing on thigh-calf garments, calf garments and foot cuffs. | | | Similarities: | The new device and the predicate device, both are portable, equipped with battery, have same intended use, components, function, working principle, operation mode, compression type, power supply, same compression cycle and similar preset pressure values, and similar conformity standards. | | | Conclusion: | Since the new device has same components, working principle, intended use, and safety features with the predicate device, they are substantial equivalent.<br>Though the two devices have slightly differences, for example, different default pressure for foot cuffs, however, the new device can be adjusted to the same pressure as the predicate device. And the adjustable pressure range for foot cuffs is same.<br>In addition, the adjustable pressure range for thigh-calf garments/calf garments of the new device is different from the predicate device, however, it is covered by the adjustable pressure range of the predicate device.<br>Except that single foot cuff can not be used with single thigh-calf garments/calf garment simultaneously, the new device and the predicate device has same application mode of garments/cuffs.<br>Any difference in technological characteristics does not raise any new safety and effectiveness issues. The conclusion drawn from the testing (Electrical Safety test, Pressure testing, Inflation/deflation time, Air leakage test, Burst testing, and so on) is that the device is substantially equivalent to the predicate device. | | . : . {5}------------------------------------------------ Dalian Labtek Science & Development Co., Ltd. # 2-2-2-2, No.4 Zhengren Street, Shahekou District, Dalian, China 116021 4. Discussion of Substantial Equivalence to the Predicate Device Veinoflow SCD system is a non-invasive medical device that delivers air to the garments and sequentially pressures them. Accordingly, the Veinoflow SCD system is intrinsically safe. Apart from the intrinsic safety of the physiological mechanism of the Veinoflow SCD system, the product components are designed to minimize potential risks to patients during product use. In particular, the product is equipped with the following safety features: 1) Audio and visual alarms are activated if inflation garments pressure either exceeds or fails to achieve recommended levels. 2 Relevant contraindications, numerous warning proper use and maintenance, are contained in the instruction manual. 3 The product labeling indicates that the device is restricted to sale by or on the order of a physician. 4 Software validation and other safety features. The Veinoflow SCD, Model LBTK-M-I 5001, has passed biocompatibility safety, electricity safety and electromagnetic compatibility safety testing according to: ISO 10993-1: 2009: Evaluation and testing within a risk management process ISO 10993-5: 2009: Tests for cytotoxicity: In vitro methods; ISO 10993-10: 2010: Tests for Irritation and Sensitization; IEC 60601-1: 2005: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. Moreover, the garments of the device and the whole system passed bench testing of: Pressure testing, Inflation/deflation time, Anti-stretch test of garment materials, Anti-stretch test of air chamber welding point, Air leakage test, Burst testing of garment, Bladder fatiguing test, and Velcro adhesion test. Veinoflow SCD system, Model LBTK-M-1 5001 has the same technological characteristics, intend use, design, function, composition and mode of operation to the predicate device. The conclusion drawn from the bench testing is that the device is substantially equivalent to the predicate device. Furthermore, the device complies with the recognized standards and performs its intended tasks as well as the legally marketed predicate device. ୧-୧ {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WQ66-G609 Silver Spring, MD 20993-0002 August 16, 2013 Dalian Labtek Science & Development Co., Ltd. c/o Doris Dong Consultant Shanghai CV Technology Co., Ltd. Room 1706, No. 128 Songle Rd., Songjiang Area Shanghai, China 201600 Re: K123830 Trade/Device Name: Veinoflow SCD, Model LBTK-M-1 5001 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 27, 2013 Received: July 16, 2013 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 docs 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. 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 {7}------------------------------------------------ Page 2 - Ms. Dong 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, M.A. Hillerman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Section 4 Indications for Use 510(k) Number (if known): K123830 Device Name: Veinoflow SCD, Model LBTK-M-I 5001 ## Indications for Use: Veinoflow SCD system, Model LBTK-M-1 5001 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5001 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency. Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) MA. Lillehemen Page 1 of ____________________________________________________________________________________________________________________________________________________________________