(100 days)
The Kendall SCD™ System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are pneumatic compression devices for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
The SCD™ System is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of DVT and PE. The SCD" System consists of a controller, a pair of tubing sets, and a pair of single-patientuse disposable sleeves. The SCD™ product line has been a standard in the mechanical DVT and PE prevention industry.
The provided document is a 510(k) premarket notification for Kendall SCD™ Sleeves and Kendall SCD Express™ Sleeves. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized representation of a human figure with three wavy lines emanating from the head, enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2006
Tyco Healthcare/Kendall c/o Ms. Bridget Gardner Manager, Regulatory Affairs 15 Hampshire Street Mansfield. MA 02048
Re: K051805
Kendall SCDTM Sleeves (Large Knee, Large Thigh, Extra Large Knee, Extra Large Thigh) Kendall SCD Express TM Sleeves (Large Knee, Large Thigh, Extra Large Knee, Extra Large Thigh) Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compressible Regulatory Class: II Product Code: JOW Dated: September 14, 2005 Received: September 15, 2005
Dear Ms. Gardner:
This letter corrects our substantially equivalent letter of October 13, 2005.
We have reviewed vour 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 (PMA). You mav. 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 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. Bridget Gardner
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 continue 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/dsma/dsmamain.html
Sincerely yours,
Dinara R. Vuitmer
\ 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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Kendall SCD™ Sleeves (Extra Large Knee, Extra Large Thigh) Kendall SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh)
Indications for Use Statement
510(k) Number (if known): 长ወና / ૪૦ / ૪૦ /
Kendall SCD" Sleeves (Large Knee, Large Thigh) Device Name: Kendall SCD Express™ Sleeves (Large Knee, Large Thigh)
Indications for Use:
ું તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્
ど
The Kendall SCD" System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Please Do Not Write Below This Line - Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-The-Counter Use_ (Per 21 CFR 801.109) Prescription Use x
Dmna R. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 65 180 5
:
Confidential
7/1/2005
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OCT 1 3 2005
Attachment #7
Summary of Safety and Effectiveness
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510(k) Summary
In accordance with section 513(l) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by:
Kendall, a Division of Tyco Healthcare 15 Hampshire Street Mansfield, MA 02048
July 1, 2005 Date Prepared:
Contact Person 1.
T
Bridget Gardner Manager, Regulatory Affairs (508) 261-6384
2. Name of Medical Device
| Proprietary Name: | Sequential Compression Sleeves |
|---|---|
| Common or Usual Name: | Sleeve, Limb, Compressible |
| Trade Name: | Kendall SCD TM Sleeves (Extra Large Knee, Extra Large Thigh)Kendall SCD Express TM Sleeves (Extra Large Knee, Extra Large Thigh) |
Identification of Legally Marketed Device 3.
The proposed devices, Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are substantially equivalent in intended use, design, function, composition and mode of operation to the currently marketed Kendall Sequential Compression Sleeves (K781357).
Device Description 4.
Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are pneumatic compression devices for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
The SCD™ System is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of DVT and PE. The SCD" System consists of a controller, a pair of tubing sets, and a pair of single-patientuse disposable sleeves. The SCD™ product line has been a standard in the mechanical DVT and PE prevention industry.
5. Device Intended Use
The Kendall SCD™ System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
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Product Comparison ଚ.
The proposed devices, Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) have the same technological characteristics, intended use, design, Extra Large Thigh) have the sume toonnelogical on currently marketed Kendall fullchoil, composition and mode of open the proposed devices and the Sequential Compression Oleovos (A) oved with an intermittent pneumatic device for predicate devices are intended to be the prevention of deep vein thrombosis.
7. Nonclinical Testing
Biocompatibility testing of the proposed devices has demonstrated that they meet the Blockhpalling testing of the proposed the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
§ 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).