IPC-BOOT

{0}------------------------------------------------ ### Special 510k Summary 13. FOR ELECTRICAL LYMPH AND VENOUS-INSUFFICIENCY SYSTEM (IPC-BOOT, model C-9000) Date Prepared: DECEMBER 20, 2006 ### 1. 510(K) OWNER NAME: C-Boot Ltd. Kibbutz Yiron, Merom Hagalil, 13855, Israel SUBMITTER PERSON NAME: Mr. Avi Abraham - Avnet Engineering -8 Marva st., Carmiel 21691, Israel Phone: +972-50-4949699 Fax: +972-4-9589111 Email: avi_abraham@yahoo.com C-BOOT LTD. U.S AGENT: 20845 Ramita Trail, Boca Raton, FL 33433, USA Contact Person: David Furshpan Phone: 561-487-6332, Fax: 561-558-1313, Email: dfurshpan@adelphia.net ### 2. DEVICE NAME Common/Usual Name: ICP-Boot Proprietary/Trade name: IPC-Boot Classification: ICP-Boot has been classified as Class II devices under the following classification names: | Name | Product<br>Code | 21 CFR Ref. | Panel | |--------------------------|-----------------|-------------|----------------| | Compressible Limb Sleeve | JOW | 870.5800 | Cardiovascular | #### 3. PREDICATE DEVICES C-Boot's new device (IPC-Boot) is substantially equivalent to C-Boot™, cleared under 510(k) number: K041659 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the letters 'DOT' in a bold, sans-serif font. The 'DOT' letters are arranged horizontally, with the 'O' in the center. The logo is black and white, and the letters are solid black. The logo is simple and modern, and it is likely used to represent a company or organization with the initials 'DOT'. #### 4. DEVICE DESCRIPTION K070329 Page 2 of 3 **IPC-Boot** is actually a very similar version Modified Device and change Description: C-Boot's IPC-Boot is actually a very similar version of C-Boot's legally marketed device, cleared under 510(k) number K041659. Similarly to the legally marketed device, it is made of the same materials and has the same design, technology and performances. The only modification that was made to the predicate device is the addition of external electric pump that can activate the device electrically when the patient is immobile. This modification provides a solution for such patients. The patient may choose whether the device will be used mechanically (self powered), by walking (as the original device) or electrically as the modified new device: IPC-Boot, when patient is immobile. The IPC-Boot is a wearable pneumatic compression technology embodied in a therapeutic boot that has the potential to increase treatment efficacy and improve the quality of life for peripheral vascular and lymph disorders patients. The IPC-Boot contains boot legging with inflatable sleeves from the patient's foot up to the knee. The IPC-Boot uses an external electric pump. The pump is generated the air to inflate the sleeves through the control system for producing intermittent compression to the lower limb. C-Boot's solution integrates the technological advantages of dynamic compression pumps that enable preset sequential pressure control which is identical to the pressure level of the preamended device (predicate). This enables the patient to individualize treatment regimes, with the mobility benefit of static compression stockings that activate the calf muscle pump and strengthened the body's natural tendency to enhance lymphatic and venous return, The modified device covers both self-powered and electrical compression devices and creates one integrated device. {2}------------------------------------------------ #### 5. INTENDED USE K070324 Page 3 of 3 The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: - Prevention of deep vein thrombosis (DVT) 1. - 2. Enhancement of blood circulation - 3. Reduction of post-operative pain and swelling - 4. Reduction of wound-healing time - న్. Stasis dermatitis - 6. Treatment and assist healing of cutaneous ulceration - 7. Venous stasis ulcers - 8. Leg ulcers - の。 Chronic venous insufficiencies - 10. Reduction of edema - 11. Prevent pooling of fluids in limbs - 12. Lymphedema #### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6. C-Boot's amended device (IPC-Boot) is substantially equivalent to C-Boot's conventional legally marketed device (C-Boot"M), cleared under 510(k) number K041659. C-Boot's new and predicate devices have the same indication for use, same basic shape, characteristics, materials, manufacturing technology and design. The modified device differs from the predicate device only in the addition of energy source, i.e., the electric pump, transformer and hose. This modification does not affecting the device's intended use and does not alter the device's fundamental scientific technology. New device verification and validation tests showed that it is as safe and as effective as the predicate device, #### 7. NONE CLINICAL PERFORMANCE DATA Tests results are supporting all labeling claims and substantial equivalency. The modified device was tested with accordance to C-Boot's legally marketed device specification and all acceptance criteria were met. #### 8. CONCLUSIONS The evaluation of C-Boot non-clinical tests demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device (thanks to the electrical operation addition). Therefore, we believe it is substantially equivalent to C-Boot's legally marketed device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The text is black against a white background. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 C-BOOT LTD C/O Avent Engineering 8 Marva Street Carmiel Israel 21691 ATTN: Avi Abraham Re: K070324 Trade/Device Name: IPC-Boot Model C-9000 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: March 19, 2007 Received: April 3, 2007 Dear Avi Abraham: 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 MAY - 3 2007 Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circular border. {4}------------------------------------------------ Mr. Avi Abraham - Page 2 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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. R. bochner Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters "IDOT" in a stylized font. The letters are arranged horizontally, with the "I" and "D" sharing a vertical line. To the left of the letters is a semi-circular shape, bisected by a white arrow pointing to the right. The logo appears to be for a transportation or infrastructure-related organization, given the abbreviation and arrow symbol. ## 4. Indication For Use Statement # 510(k) Number (if known): _K070324 # Device Name: Electrical Lymph and Venous-Insufficiency System (IPC-Boot) Indications for Use: The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The IPC-Boot is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: - Prevention of deep vein thrombosis (DVT) 1. - Enhancement of blood circulation 2. - Reduction of post-operative pain and swelling 3. - 4. Reduction of wound-healing time - న్. Stasis dermatitis - 6. Treatment and assist healing of cutaneous ulceration - 7. Venous stasis ulcers - Leg ulcers 8. - Chronic venous insufficiencies の - 10. Reduction of edema - 11. Prevent pooling of fluids in limbs - 12. Lymphedema | Prescription Use | ✓ | |-----------------------------|---| | (Part 21 CFR 801 Subpart D) | | AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dura R. Holmes (Posted November 13, 2003) (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_K070324