(87 days)
Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only
Reprocessed Used Disposable Sequential Compression Sleeves
The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) "substantially equivalent" letter from the FDA to a medical device manufacturer. It primarily discusses:
- Device Identification: Reprocessed Used Disposable Sequential Compression Sleeves (K022753).
- Regulatory Classification: Class II, Product Code JOW.
- FDA Determination: The device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Regulatory Requirements: General controls, good manufacturing practices, labeling, advertising, and other compliance aspects.
- Intended Use Statement: "Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients. Sequential compression sleeves are single patient use devices only."
The letter explicitly states 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." Substantial equivalence is determined by comparing the device to a predicate device, not necessarily by requiring the submission of new clinical or performance study data with specific acceptance criteria.
Therefore, I cannot provide the requested information as it is not present in the given text.
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Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is left-aligned and in a simple font.
NOV 2 0 2002
Medical Device Services c/o Mr. Mark W. Aldana President 1001 Slaton Hwy. Lubbock, TX 79404
Re: K022753
Trade Name: Reprocessed Used Disposable Sequential Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Pumps and Sleeves Regulatory Class: Class II (two) Product Code: JOW Dated: August 9, 2002 Received: August 13, 2002
Dear Mr. Aldana:
This letter corrects our substantially equivalent letter of November 14, 2002 regarding the incorrect applicant.
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 - Mr. Mark W. Aldana
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 (OS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
B. Z. Jantzen, M.D.
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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Page I of I
510)k) Number:
Device Name:
Indications For Use
Sequential compression sleeves are intended to increase venous comment contrallym in por as a prophylaxis for the formation of deep vein thrombosis or pulmonary embolism in non ambulatory patients.
Sequential compression sleeves are single patient use devices only
Image /page/2/Figure/11 description: The image contains a text instruction. The instruction says, "(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF, NEEDED)". This instruction is likely intended for a form or document where users should not write in a specific area and can continue on another page if necessary. The text is written in a formal tone.
Image /page/2/Figure/12 description: The image shows a document related to the Concurrence of CDRH, Office of Device Evaluation (ODE). It includes references to Division 510(k) and mentions "Division of Cardiovascular & Respiratory Devices". The document also contains the number K022753 and a date, 11/13/02, along with the terms "Prescription Use" and "Over-The-Counter Use", indicating the intended use of the device.
§ 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).