(136 days)
The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to 6 hours.
The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is a sterile, single-use, open-ended, hollow polymer tube with multiple perforations at the distal end. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. The RAP FV cannula is provided with a flexible obturator to assist with the placement. The RAP FV cannula can be guided over a 0.035" guidewire. The RAP FV cannula has depth markers to assist the physician with placement. The RAP FV cannula ranges in outside diameter from 18 - 26 Fr, and in length from 60 -76 cm.
The provided document is a 510(k) premarket notification for a medical device (ESTECH Remote Access Perfusion FV Catheter). The information requested pertains to the acceptance criteria and the study proving the device meets those criteria, which is typical for AI/ML device submissions. However, this document does not contain any information about an AI/ML device.
The document describes a physical medical device (a cardiopulmonary bypass cannula) and its substantial equivalence to predicate devices. It discusses:
- Device Description: A sterile, single-use, open-ended, hollow polymer tube with multiple perforations.
- Intended Use: As a venous drainage cannula during cardiopulmonary bypass.
- Comparison to Predicate Device: Substantially equivalent in terms of sterile, single-use, open-ended, hollow polymer tubes inserted into the vena cava via the femoral vein.
- Supporting Data: Biocompatibility testing consistent with ISO 11193 and preclinical performance data to demonstrate labeled performance claims and substantial equivalence.
Therefore, I cannot provide the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) because these concepts are not applicable to the non-AI/ML device described in the provided text.
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DEC 16 2005
Endoscopic Technologies, Inc.
ESTECH Remote Access Perfusion FV Catheter Premarket Notification Exemption
SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Category | Comments |
|---|---|
| Sponsor: | Estech4135 Blackhawk Plaza Circle.Suite 150Danville, CA 94506Tel: 925-648-3500 |
| Correspondent: | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140 |
| Contact Information: | Fax: 510-337-0416 |
| Device Common Name: | Cardiopulmonary bypass catheter, cannulaor tubing |
| Device Proprietary Name: | Remote Access Perfusion (RAPTM)Femoral Venous Cannula |
| Device Classification Name: | Cardiopulmonary bypass catheter, cannulaor tubing, 21 CFR 870.4210 |
| Device Classification & Code: | Class II. DWF |
Predicate Device Information:
| Predicate Devices: | ULTRAFLEX™ Venous Cannula(K031827)RMI Fem-Flex Femoral Access CannulationSet (K891576) |
|---|---|
| Predicate Device Manufacturers: | MedtronicResearch Medical Incorporation |
| Predicate Device Common Name: | Cardiopulmonary bypass catheter, cannula ortubing |
| Predicate Device Classification: | 21 CFR 870.4210 |
| Predicate Device Classification & Code: | Class II, DWF |
b. Date Summary Prepared
July 25, 2005
c. Description of Device
The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is a sterile, single-use, open-ended, hollow polymer tube with multiple perforations at the distal end. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures.
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The RAP FV cannula is provided with a flexible obturator to assist with the placement The RAI TV cannula is provided can be guided over a 0.035" guidewire. The RAP FV allu positioning of the bailing to and depth markers to assist the physician with placement.
The RAP FV cannula ranges in outside diameter from J8 - 26 Fr, and in length from 60 -76 cm.
d. Intended Use
ilued Use
The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass.up To 6 houls ,
e. Comparison to Predicate Device
e. Comparison to Predicate Device
The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is substantially The Estoon Remote Prose, technology, design and materials to the predicate devices.
The Estech RAP Femoral Venous Cannula is substantially equivalent to the Medtronic I IIC Ecorp Venous Cannula (K031827) and the RMI Fem-Flex Femoral Access Cannulation Set (K891576).
The current and predicate devices are sterile, single use, open-ended, hollow polymer tubes inserted into the vena cava via the femoral vein. They are all intended to be used with cardiopulmonary bypass equipment as venous drainage cannula.
f. Summary of Supporting Data
If Summal y of Supporting Data
Biocompatibility testing consistent with ISO 11193 is presented in Section 6. All components of the Estech RAP Femoral Venous Cannula passed the testing.
Preclinical performance data was supplied to demonstrate that the RAP FV cannula can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
DEC 16 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coombs Medical Device Consulting c/o Mr. Craig Coombs President 1193 Sherman Street Alameda, CA 940501
Re: K052081
K052081
Remote Access Perfusion (RAPTM) Femoral Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: 21 CH 070.1210
Regulation Name: Cardiopulmonary Bypass Catheter, Cannula or Tubing Regulatory Class: Class II (Two) Product Code: DWF Dated: October 24, 2005 Received: October 26, 2005
Dear Mr. Coombs:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaint is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced peopless (Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug. commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that to not require approved controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general provision You may, merelore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements michranding and general controls provisions of the rict morations against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FITA may be subject to such additional controls. Existing major be found in the Code of Poderal Regaring your device in the Federal Register.
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Page 2 - Mr. Craig Coombs
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 losames or our device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any I cuchares and regarations and regarations and limited to: registration and listing (21 Comply with an the Fee 610 care and 301); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product launation conta of pro note (stime (eting your device as described in your Section 510(k) I his icher wif anow you to organization of substantial equivalence of your device to a legally prematics notification: "The Pressification 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 If you desire specific arriouse at (240) 276-0120. Also, please note the regulation entitled, Connect the Office of Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Duma R. Ladner
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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): とらこ 08 |
Remote Access Perfusion (RAP™) Femoral Venous Cannula Device Name:
Indications For Use:
The ESTECH Remote Access Perfusion Femoral Venous Cannula - during The ESTECH Remote Association rainage cannula during cardiopulmonary bypass up to 6 hours.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Dune P. Vachner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052081
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).