ALP 501 RB PUMP SYSTEM

{0}------------------------------------------------ #### 510 (k) SUMMARY SEP - 1 2011 # ALP® 501 RB Pneumatic Compression System 510 (k) Number K | | 23 \ # Applicant's Name: Currie Medical Specialties Inc. 730 East Los Angeles Avenue Monrovia, California 91762 Tel .: 626-303-3521 Fax: 626-303-3957 #### Contact Person: Bernice Navarro, Vice President Quality Assurance Currie Medical Specialties Inc. 730 East Los Angeles Avenue Monrovia, California 91762 Tel.: 626-303-3521 Fax: 626-303-3957 #### Date Prepared: July, 2011 #### Trade Name: ALP® 501 RB Pneumatic Compression System #### Classification Name: Compressible Limb Sleeve #### Classification: Class II Product Code: JOW Regulation No. 870.5800 {1}------------------------------------------------ ### Statement of Substantial Equivalence: The ALP® 501 RB Pneumatic Compression System is substantially equivalent in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., to the commercially available ALP® 501 Pump System. The changes between the two systems include the addition of an optional battery operated unit and change in inner components. # Device Description: The ALP® 501 RB Pump is a prescriptive, pneumatic compression device designed to apply compression to the lower limb. The ALP® 501 RB pump is compact this making it a portable ambulant system. The ALP® 501 RB pump provides the user with an option of battery operation in addition to the operation from the mains option. The ALP® 501 RB pump is easy to use and provides the user with three treatment options: compression of the foot, compression of the calf, or combined compression of both (one foot and one calf). The foot and calf compression program fills a garment bladder and decompresses. The device is composed of three main sub-systems: - 1) A portable pneumatic pump unit, - 2) A pair of garments (calf and/or foot) and - 3) Pneumatic connecting tubes. Inflation and deflation of the garments are controlled by the pump system. The inflation and deflation produces a massage on the patient limb in order to stimulate the natural flow of the body fluids. ### Indications: The ALP® 501 RB Pump System is a prescriptive device that induces controlled compression of the calf, the thigh, and the foot or combined compression. The ALP® 501 RB Pump System is intended for use by patients and medical professionals in treating many conditions, such as: - Reduce the incidence of deep vein thrombosis (DVT) and pulmonary . embolism due to the presence of risk factors for thrombosis formation - Enhancement of arterial blood flow . - Reduction of post-operative pain and swelling . - Reduction of compartmental pressure after tissue trauma . {2}------------------------------------------------ #### Contraindications: The ALP® 501 RB Pump system should not be used in the following cases: Gangrene, recent skin graft, severe arteriosclerosis or other ischemic vascular disease, congestive cardiac failure, massive edema, pulmonary edema, existing DVT, acute thrombophlebitis, acute infections and during episodes of pulmonary embolism. # Performance Date: A series of safety and performance testing including comparative analysis between the ALP® 501 RB Pump system and the ALP® 501 Pump System demonstrated that the ALP® 501 RB Pump System is substantially equivalent to the ALP® 501 Pump System without raising new safety and/or effectiveness issues. {3}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the 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 an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of three curved lines that form the shape of a person's head and body. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002 Currie Medical Specialties, Inc. c/o Ms. Bernice Navarro Vice President Quality Assurance 730 East Los Angeles Avenue Monrovia, CA 91762 SEP - 1 2011. Re: K112311 ALP® 501 RB Pneumatic Compression System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 10, 2011 Received: August 11, 2011 Dear Ms. Navarro: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) premainer is substantially equivalent (for the indications referenced above and have determined the device is subsets marketed in intersi referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to legally marketed previce. Device Amendments, for use stated in the enclosure) to regard manked to wice Amendon Device Amendments, or to commerce prior to May 28, 1976, the enactment date of the Federal Food. Drue, commerce prior to May 28, 1976, the enactinent and of the Federal Food, Drug, devices that have been reclassified in accordance with as proval application (PMA). and Cosmetic Act (Act) that do not require approval assessed approval applications of the and Cosmetic Act (Act) that do not require approvation provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the general registration, listing of general controls provisions of the Act include requirements misbranding and general controls provisions of the Act Include reading magazinst misbranding and devices, good manufacturing practice, labeling in the promotion related to contract liability. adulteration. Please note: CDRH does not evaluate information truthing and no adulteration. Please note: CDRF does not evaluate information of misleading. 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 in be If your device is classified (see above) into ennot electing your device can be {4}------------------------------------------------ Page 2 - Ms. Bernice Navarro 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 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. ff 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 yours, EV Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ K112311 # INDICATIONS FOR USE # 510 (k) Number (if known):_K112311 ### Device Name: # ALP® 501 RB Pneumatic Compression System #### Indications for Use: The ALP® 501 RB Pump system is a prescriptive device that induces controlled compression of the calf, the foot or combined compression of both. The ALP® 501 RB Pump System is intended for use by patients and medical professionals in treating many conditions, such as: - . - Reduce the incidence of deep vein thrombosis (DVT) and pulmonary ● embolism due to the presence of risk factors for thrombosis formation - . Enhancement of arterial blood flow - Reduction of post-operative pain and swelling . - Reduction of compartmental pressure after tissue trauma . # (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED 510 (k) Number K112311 Prescriptive Use ✗ (Per 21 CFR 801.109) OR Over the Counter Use **__** (Division Sign-Off) Division of Cardiovascular Devices S8-6 510(k) Number K112311