(92 days)
The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.
The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures. The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.
The provided text describes a medical device, the ESTECH Clearview™ MV Atrial Depressor, and its regulatory submission. It does not contain information about acceptance criteria for device performance, nor details of a study (clinical or otherwise) proving it meets such criteria. The document is primarily a 510(k) summary for regulatory approval, focusing on substantial equivalence to predicate devices, biocompatibility, and preclinical performance data.
Therefore, I cannot provide the requested information. The text explicitly states "Preclinical performance data was supplied to demonstrate that the Estech Clearview™M MV Atrial Depressor can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate device," but it does not provide the details of this data or the specific acceptance criteria.
The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, etc.) are typical for studies assessing the diagnostic accuracy or effectiveness of AI/imaging devices. The device described here is a surgical instrument for fluid collection and tissue retraction, and its performance evaluation would likely focus on different metrics (e.g., fluid collection rate, suction integrity, material strength, biocompatibility, ease of use in a surgical setting) rather than accuracy against a ground truth in an AI context.
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Endoscopic Technologies, Inc.
KOS 3021 RG 1 of 2
ESTECH Clearview MV Atrial Depressor Premarket Notification
Section 5: 510(k) Summary
Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Estech4135 Blackhawk Plaza Circle.Suite 150Danville, CA 94506Tel: 925-648-3500 |
| Correspondent ContactInformation: | Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416 |
| Device Common Name: | Cardiopulmonary bypass cardiotomy return sucker |
| Device Classification & Code: | Class II, DTS (21 CFR 870.4420) |
| Device Classification Name: | Sucker, Cardiotomy Return, CardiopulmonaryBypass |
| Device Proprietary Name: | Estech Clearview™ MV Atrial Depressor |
Predicate Device Information:
| Predicate Devices: | California Medical Laboratories Rigid TipSuction Wands (K982891)IBC Cardiac Suction Wand (K963756) |
|---|---|
| Predicate Device Manufacturers: | California Medical LaboratoriesInternational Biophysics Corporation |
| Predicate Device Common Name: | Cardiopulmonary bypass cardiotomy returnsucker |
| Predicate Device Classification: | 21 CFR 870.4420 |
| Predicate Device Classification & Code: | Class II, DTS |
b. Date Summary Prepared
13 January 2006
c. Description of Device
The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures.
The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field
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via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.
d. Intended Use
The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.
e. Comparison to Predicate Device
The Estech Clearview™ MV Atrial Depressor is substantially equivalent in intended use. technology, design and materials to the predicate devices.
The Estech Clearview™ MV Atrial Depressor is substantially equivalent to the California Medical Laboratories Rigid Tip Suction Wands (K982891) and the IBC Cardiac Suction Wand (K963756).
The current and predicate devices are sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery.
f. Summary of Supporting Data
Biocompatibility testing consistent with ISO 10993 is presented in Section 15. All components of the Estech Clearview™MV Atrial Depressor passed the testing.
Preclinical performance data was supplied to demonstrate that the Estech Clearview™M MV Atrial Depressor can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate device
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 6 2006
Coombs Medical Device Consulting c/o Mr. Craig Coombs President 1193 Sherman Street Alameda, CA 94501
Re: K053021
ESTECH Clearview™M MV Atrial Depressor Regulation Name: Cardiopulmonary Bypass Cardiotomy Return Sucker Regulatory Class: II Product Code: DTS Dated: January 10, 2006 Received: January 12, 2006
Dear Mr. Coombs:
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 interstatc 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, I'DA may publish further announcements concerning your device in the Federal Register.
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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.
Duna R. Lichner
\ 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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KØ53Ø21
Endoscopic Technologies, Inc.
ESTECH Clearview MV Atrial Depressor Requested Information - K053021
Section 4: Indications for Use Statement
510(k) Number (if known): Ko53021
ESTECH Clearview™ MV Atrial Depressor Device Name:
Indications For Use:
The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.
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)
Darra R. Vac
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_k05302 | _______________________________________________________________________________________________________________________________________________________
§ 870.4420 Cardiopulmonary bypass cardiotomy return sucker.
(a)
Identification. A cardiopulmonary bypass cardiotomy return sucker is a device that consists of tubing, a connector, and a probe or tip that is used to remove blood from the chest or heart during cardiopulmonary bypass surgery.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.