(229 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and heparin coating of the cannulae, with no mention of AI or ML.
Yes
The device is indicated for use in perfusion of the ascending/descending aorta during cardiopulmonary bypass surgery, which is a therapeutic intervention.
No
The device is a cannula used for perfusion during cardiopulmonary bypass surgery, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly describes a physical medical device (cannulae) made of materials like metal or plastic, with varying sizes, shapes, and features. It also mentions a surface treatment (Duraflo® Treatment). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "perfusion of the ascending aorta during cardiopulmonary bypass surgery" and "perfusion of the descending thoracic aorta during cardiopulmonary bypass surgery." This describes a device used in vivo (within the body) to facilitate a surgical procedure.
- Device Description: The description details a physical device (cannulae) used to deliver fluid into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) on biological samples. This device is clearly intended for direct use within the patient's circulatory system during surgery.
N/A
Intended Use / Indications for Use
The Sarns Aortic Arch Cannulae with Duraflo® Treatment, Flexible Arterial Cannulae with Duraflo® Treatment, High Flow Aortic Arch Cannulae with Duraflo Treatment, Soft Arc Cannula with Duraflo Treatment, D4 Cannulae with Duraflo Treatment, and the Soft Flow Cannulae with Duraflo Treatment are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The Sarns Flexible Aortic Arch Cannula with Duraflo Treatment is indicated for use in perfusion of the descending thoracic aorta during cardiopulmonary bypass surgery.
Product codes (comma separated list FDA assigned to the subject device)
74 DWF
Device Description
The only difference between the Sams Arterial Cannulae and the Sarns Arterial Cannulae with Duraflo® Treatment is the addition of the Duraflo® Treatment. As a result of this process, a layer of heparin is deposited on the inside and outside of the cannula tip, tube, and connector. Like their predicate devices, the Sarns Arterial Cannulae with Duraflo® Treatment are sterile, single-use medical devices. They are available in sizes ranging from 3.8 mm to 8.0 mm outer diameter tip sizes, with tips being straight or angled, soft or rigid, metal or plastic. Several styles of the Sarns Arterial Cannulae are available in both wire-reinforced and non-wire-reinforced tube styles. Other features include an optional suture flange on some models as well as an optional Luer port for the venting of air.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ascending aorta, descending thoracic aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance: The performance characteristics of selected models were chosen as being representative of the technological attributes of all models of Sarns Arterial Cannulae) of the Sarns Arterial Cannulae with Duraflo® Treatment were exhaustively tested and compared with the performance characteristics of the currently marketed Sarns Arterial Cannulae. All new and existing performance characteristics of the Sarns Arterial Cannulae with Duraflo® Treatment have been validated.
Clinical Performance: Clinical testing was not performed on these devices.
Conclusions from Nonclinical Tests: The Sarns Arterial Cannulae with Duraflo® Treatment perform as intended according to their performance specifications. The Sarns Arterial Cannulae with Duraflo® Treatment are substantially equivalent to their predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K934127, K874896, K834134, K771499, K770429, Preamendment
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by flowing lines that suggest a profile view.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN | 8 1997
Mr. Jason Smith Requlatory Affairs Coordinator 3M Health Care Cardiovascular Systems ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Sarns and CDI Products 6200 Jackson Road Ann Arbor, Michigan 48103-9300
Re: * K964373 Sarns Arterial Cannulae with Duraflo® Treatment Regulatory Class: II (Two) Product Code: 74 DWF Dated: April 9, 1997 Received: April 10, 1997
Dear Mr. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Jason Smith
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advettising 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address"dsmo@fdadr.cdrh.fda.gov."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _ K 964373/5001
Device Name: Sarns Arterial Cannulae with Duraflo Treatment
Indications For Use: . . . . . . .
The Sarns Aortic Arch Cannulae with Duraflo Treatment, Flexible Arterial Cannulae with Duraflo Treatment, High Flow Aortic Arch Cannulae with >> Duraflo Treatment, Soft Arc Cannula with Duraflo Treatment, D4 Cannulae with Duraflo Treatment, and the Soft Flow Cannulae with Duraflo Treatment are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
The Sarns Flexible Aortic Arch Cannula with Duraflo Treatment is indicated for use in perfusion of the descending thoracic aorta during cardiopulmonary bypass surgery.
Page 18 of 210
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chona Schakee Hicks
(Division Sign-Off)
(Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
escription Use
'er 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
3
JUN 18 1997
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is
Submitter's Name: 3M Health Care Submitter's Address: 6200 Jackson Road, Ann Arbor, Michigan 48103 Contact Person: Jason Smith Phone Number: (313) 663-4145 FAX Number: 663-5062 (313) Summary Date:
Device Trade Names:
Sarns Aortic Arch Cannulae with Duraflo® Treatment, Sarns Flexible Aortic Arch Cannula with Duraflo® Treatment, Sarns Flexible Arterial Cannulae with Duraflo® Treatment, Sarns High Flow Aortic Arch Cannulae with Duraflo® Treatment, Sarns Soft-Arc Cannula with Duraflo® Treatment, Sarns D4 Cannulae with Duraflo® Treatment, Sarns Soft Flow Cannulae with Duraflo® Treatment
Device Classification Name:
"Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing" (21 CFR 870.4210)
Predicate Devices:
The Sarns Arterial Cannulae with Duraflo® Treatment are substantially equivalent to the existing Sarns Arterial Cannulae (510(k) clearance numbers listed in the table below].
| Cannula Type | 510(k) Number | Clearance Date |
|---|---|---|
| Soft Flow | K934127 | 2/22/94 |
| D4 | K874896 | 2/2/88 |
| Soft-Arc | K834134 | 4/17/84 |
| Flexible Arterial | K771499 | 8/16/77 |
| High Flow Aortic Arch | K770429 | 3/16/77 |
| Aortic Arch, Flexible Aortic Arch | Preamendment |
Device Description:
The only difference between the Sams Arterial Cannulae and the Sarns Arterial Cannulae with Duraflo® Treatment is the addition of the Duraflo® Treatment. As a result of this process, a layer of heparin is deposited on the inside and outside of the cannula tip, tube, and connector. Like their predicate devices, the Sarns Arterial Cannulae with Duraflo® Treatment are sterile, single-use medical devices. They are available in sizes ranging from 3.8 mm to 8.0 mm outer diameter tip sizes, with tips being straight or angled, soft or rigid, metal or plastic. Several styles of the Sarns Arterial Cannulae are available in both wire-reinforced and non-wire-reinforced tube styles. Other features include an
4
optional suture flange on some models as well as an optional Luer port for the venting of air.
Indications for Use:
The Sarns Aortic Arch, Flexible Aortic Arch, High Flow Aortic Arch, Flexible Arterial, D4. and Soft Flow Cannulae with Duraflo® Treatment are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgerv. The Sarns Flexible Aortic Arch Cannula with Duraflo® Treatment is indicated for use in perfusion of the descending thoracic aorta during cardiopulmonary bypass surgery.
Technological Characteristics:
The only difference between the Sarns Arterial Cannulae and the Sarns Arterial Cannulae with Duraflo® Treatment is the addition of the Duratio® Treatment. As a result of this process, a layer of heparin is deposited on the inside of the cannula tip, tube. and connector. There will be no dimensional changes to the cannulae due to the addition of the Duraflo® Treatment :コートレート |
Nonclinical Performance:
The performance characteristics of selected models were chosen as being representative of the technological attributes of all models of Sarns Arterial Cannulae) of the Sarns Arterial Cannulae with Duraflo® Treatment were exhaustively tested and compared with the performance characteristics of the currently marketed Sarns Arterial Cannulae. All new and existing performance characteristics of the Sarns Arterial Cannulae with Duraflo® Treatment have been validated.
Clinical Performance:
Clinical testing was not performed on these devices.
Conclusions from Nonclinical Tests:
The Sarns Arterial Cannulae with Duraflo® Treatment perform as intended according to their performance specifications. The Sarns Arterial Cannulae with Duraflo® Treatment are substantially equivalent to their predicate devices.
Page 15 of 210