(307 days)
When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients. The compression garments are prescription devices intended for a single patient use only.
Compressible limb sleeves are devices that are used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb and increasing venous flow. Compression therapy is generally prescribed as a prophylaxis for deep vein thrombosis (DVT). The compression system consists of two primary pieces: an air compression pump and a soft, flexible sleeve in which the patient's extremity is placed. A hose to the pump connects to the sleeve, and when the pump is turned on, the air inflates the sleeve, applying a gentle pressure to the patient's extremity. Compression garments consist of a non-woven fabric with "hook and loop" fasteners for attaching around the leg. Air cells within the garment are molded to plastic hoses with connectors for attachment to the pump. The hoses and connectors are non-detachable and are reprocessed as part of the garment. Vanguard Reprocessed Compression Garments (Hill-Rom) contain multiple compartments and hoses that are sequentially pressurized. Vanguard receives previously used compression garments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the garments; and returns them to a healthcare facility.
The provided text is a 510(k) summary for the Vanguard Reprocessed Compression Garments (Hill-Rom). This document describes a medical device and its substantial equivalence to predicate devices, focusing on reprocessing. It does not contain information about a study that establishes acceptance criteria for AI/ML device performance or involves human readers, experts, or ground truth establishment relevant to AI/ML device evaluation.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets.
The document discusses:
- Cleaning, packaging, and sterilization validations: These demonstrate that the reprocessed devices perform as intended and are safe and effective.
- Performance and biocompatibility testing: These also support the safety and effectiveness of the reprocessed devices.
- Sterilization validation: This specifically demonstrates that sterility is achieved to a 10^-6 assurance level using ethylene oxide gas.
These are related to the physical reprocessing of the garments and ensuring they meet the same specifications and safety profiles as new, non-sterile garments. They are not related to an AI/ML device's diagnostic or predictive performance.
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510(k) Summary of Safety & Effectiveness
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Heather Crawford, RACDirector of Regulatory Affairs863-683-8680 [voice]863-904-2250 [facsimile]hcrawford@safe-reuse.com [email] |
| Date | June 1, 2005 |
| Device | Trade Name: Vanguard Reprocessed Compression Garments (Hill-Rom)Common Name: Compression Limb Sleeve, Compression Garment, SCDClassification: 21 CFR 870.5800Classification Name: Compressible Limb SleeveDevice Class: Class IIProduct Code: JOW |
| Predicate Devices | Trade Name: Hill-Rom ActiveCare™ DVT 510(k) number: K002287, K012994 [510(k) clearance received by Medical Compression Systems, Ltd.]Vanguard Reprocessed Compression Garments 510(k) number: K012403 |
| Indications for Use | When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients. The compression garments are prescription devices intended for a single patient use only. |
Continued on next page
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510(k) Summary of Safety & Effectiveness, Continued
Compression therapy is contraindicated in patients with: Contrarisk factors for pre-existing DVT or PE, including prolonged bed rest indications . congestive heart failure and associated edema of legs, feet or lungs . severe arteriosclerosis or other vascular ischemic disease . localized skin conditions (dermatitis, vein ligation, gangrene, skin graft) . acute stages of inflammatory phlebitis . any condition where increased venous or lymphatic return is undesired. . Compressible limb sleeves are devices that are used to prevent pooling of Device blood in a limb by inflating periodically a sleeve around the limb and Description increasing venous flow. Compression therapy is generally prescribed as a prophylaxis for deep vein thrombosis (DVT). The compression system consists of two primary pieces: an air compression pump and a soft, flexible sleeve in which the patient's extremity is placed. A hose to the pump connects to the sleeve, and when the pump is turned on, the air inflates the sleeve, applying a gentle pressure to the patient's extremity. Compression garments consist of a non-woven fabric with "hook and loop" fasteners for attaching around the leg. Air cells within the garment are molded to plastic hoses with connectors for attachment to the pump. The hoses and connectors are non-detachable and are reprocessed as part of the garment. Vanguard Reprocessed Compression Garments (Hill-Rom) contain multiple compartments and hoses that are sequentially pressurized. Vanguard receives previously used compression garments from healthcare facilities; cleans, inspects, tests, repackages and sterilizes the garments; and returns them to a healthcare facility. The Vanguard reprocessed compression garments are essentially identical to Technological Characteristics the currently marketed OEM compression garments. No changes are made to the currently marketed devices' specifications (with the exception of sterility), and they possess the same technological characteristics. The OEM devices are marketed as non-sterile: Vanguard reprocessed compression garments are sterilized with ethylene oxide gas. Vanguard's sterilization validation demonstrates that sterility is achieved to a 10 assurance level. Continued on next page
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510(k) Summary of Safety & Effectiveness, Continued
- Cleaning, packaging, and sterilization validations, and performance and Test Data biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective.
Based upon the information provided herein and the 510(k) "Substantial Conclusion Equivalence'' Decision Making Process Chart, we conclude that the Vanguard Reprocessed Compression Devices are substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a symbol of three stylized, curved lines that resemble birds in flight. The text in the border is small and difficult to read, but it appears to follow the curve of the circle. The overall design is simple and monochromatic, with a focus on the abstract representation of flight or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 4 2006
Vanguard Medical Concepts, Inc. c/o Ms. Trish Stephens Project Manager, Research and Development 5307 Great Oak Drive Lakeland, FL 33815
Re: K051438
Vanguard Reprocessed Compression Garments (Hill-Rom) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II (two) Product Code: JOW Dated: February 3, 2006 Received: February 6, 2006
Dear Ms. Stephens:
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.
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Page 2 - Ms. Trish Stephens
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. 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,
Donald P. Lussier
ட் Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 长 o ५) 4 ろ ダ
Device Name: Vanguard Reprocessed Compression Garments (Hill-Rom)
Indications for Use:
When coupled with an appropriate inflation system, compression garments are intended to increase venous return from the legs and feet as a prophylaxis for the formation of deep vein thrombosis (DVT) or subsequent pulmonary embolism (PE) in high risk and/or non-ambulatory patients.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diving R. Richard
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_K651438
Page 1 of 1
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).