(229 days)
Not Found
No
The summary describes a physical medical device (catheters) with a heparin coating. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is used for venous drainage during cardiopulmonary bypass surgery, which is a supportive procedure, not a therapeutic one that treats a disease or condition directly.
No
Explanation: The device is a venous return catheter used for drainage during cardiopulmonary bypass surgery, not for diagnosing medical conditions.
No
The device description clearly describes physical catheters made of tubing with a heparin coating, which are hardware components. There is no mention of software as part 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 clearly describes the device's function as a catheter for venous drainage during cardiopulmonary bypass surgery. This is a surgical procedure performed on a patient's body.
- Device Description: The description details the physical characteristics of the catheter, its sizes, and the addition of a heparin coating. It describes a device used in vivo (within the body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
The device is a medical device used directly on a patient during surgery, not an IVD used for testing specimens.
N/A
Intended Use / Indications for Use
The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery. The Sarns Two Stage Venous Return, Dual Stage Venous Return, and Venoatrial Catheters with Duraflo® Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardiopulmonary bypass surgery.
Product codes (comma separated list FDA assigned to the subject device)
74 DWF
Device Description
The only difference between the Sarns Venous Return Catheters with Duraflo® Treatment and the Sarns Venous Return Catheters 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 catheter tip, tube, and connector.
As with their predicate devices, all of the Sarns Venous Return Catheters with Duraflo® Treatment are sterile, single-use medical devices. The Sarns Venous Return Catheters with Duraflo® Treatment are available in sizes ranging from 8 French to 51 French. (The French size is the outer diameter of the catheter in millimeters multiplied by three.). The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are available as a single tube. The Sarns Two Stage, Venoatrial, and Dual Stage Venous Return Catheters with Duraflo® Treatment consist of two differently-sized tubes. Many different models of the Sarns Venous Return Catheters with Duraflo® Treatment are available with wire-reinforced tubing. Some models of the multi-stage . versions of the Sarns Venous Return Catheters with Duraflo® Treatment have an integral connector. Additionally, the Sarns Venous Return Catheters with Duraffo® Treatment have been coated with heparin via the Duraflo® Treatment process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superior and inferior vena cava, right atrium and vena cava
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 Venous Return Catheters) of the Sarns Venous Return Catheters with Duraflo® Treatment were tested and compared with the performance characteristics of the currently marketed Sarns Venous Return Catheters. All new and existing performance characteristics of the Sarns Venous Return Catheters with Duraflo® Treatment have been validated.
Clinical Performance: Clinical testing was not performed on these 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.
K905224, K875048, K810415, K790246, K770431, 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
JUN 18 58
15964374
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 6200 Jackson Road, Ann Arbor, Michigan 48103 Submitter's Address: Jason Smith Contact Person: (313) 663-4145 Phone Number: 663-5062 FAX Number: (313) Summary Date:
Device Trade Names:
Sarns Venous Return Catheters with Duraflo® Treatment, Sarns Right Angle Venous Return Catheters with Duraflo® Treatment, Sarns Two Stage Venous Return Catheters with Duraflo® Treatment, Sarns Venoatrial Catheters with Duraflo® Treatment, Sarns Dual Stage Venous Return Catheters with Duraflo® Treatment.
Device Classification Name:
"Cardiopulmonary Bypass Vascular Catheter, Cannuia, or Tubing" (21 CFR 870.4210)
Predicate Devices:
The Sarns Venous Return Catheters with Duraflo® Treatment are substantially equivalent to the existing Sarns Venous Return Catheters [510(k) clearance numbers listed in the table below].
| Catheter Type | 510(k) Number | Clearance Date |
|---|---|---|
| 20, 24, 28, and 32 French Size (Fr.) | ||
| non-wire Venous Return Catheter sizes; | ||
| 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, | ||
| 30, and 34 Fr. wire-reinforced Venous | ||
| Return Catheter sizes, Right Angle Venous | ||
| Return Catheters | K905224 | 2/5/91 |
| Venoatrial Catheters | K875048 | 2/18/88 |
| Two Stage Venous Return Catheters | ||
| (wire-reinforced), Dual Stage Venous | ||
| Return Catheters | K810415 | 3/17/81 |
| 32, 36, and 40 Fr. wire-reinforced | ||
| Venous Return Catheters | K790246 | 3/2/79 |
| Two Stage Venous Return Catheters (non- | ||
| wire-reinforced) | K770431 | 3/16/77 |
| 32, 26, 40 and 51 Fr. Venous Return | ||
| Catheters | Preamendment |
1
Device Description:
The only difference between the Sarns Venous Return Catheters with Duraflo® Treatment and the Sarns Venous Return Catheters 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 catheter tip, tube, and connector.
As with their predicate devices, all of the Sarns Venous Return Catheters with Duraflo® Treatment are sterile, single-use medical devices. The Sarns Venous Return Catheters with Duraflo® Treatment are available in sizes ranging from 8 French to 51 French. (The French size is the outer diameter of the catheter in millimeters multiplied by three.). The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are available as a single tube. The Sarns Two Stage, Venoatrial, and Dual Stage Venous Return Catheters with Duraflo® Treatment consist of two differently-sized tubes. Many different models of the Sarns Venous Return Catheters with Duraflo® Treatment are available with wire-reinforced tubing. Some models of the multi-stage . versions of the Sarns Venous Return Catheters with Duraflo® Treatment have an integral connector. Additionally, the Sarns Venous Return Catheters with Duraffo® Treatment have been coated with heparin via the Duraflo® Treatment process.
Indications for Use:
The Sarns Standard and Right Angle Venous Return Catheters with Duraflo® Treatment are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery. The Sarns Two Stage Venous Return, Dual Stage Venous Return, and Venoatrial Catheters with Duraflo® Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardiopulmonary bypass surgery.
Technological Characteristics:
The only difference between the Sarns Venous Return Catheters with Duraflo® Treatment and the Sarns Venous Return Catheters 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 catheter tip, tube, and connector. There will be no dimensional changes to the catheters due to the addition of the Duraflo® Treatment.
Nonclinical Performance:
The performance characteristics of selected models were chosen as being representative of the technological attributes of all models of Sarns Venous Return Catheters) of the Sarns Venous Return Catheters with Duraflo® Treatment were tested and compared with the performance characteristics of the currently marketed Sarns Venous Return Catheters. All new and existing performance characteristics of the Sarns Venous Return Catheters with Duraflo® Treatment have been validated.
Clinical Performance:
Clinical testing was not performed on these devices.
2
Conclusions from Nonclinical Tests:
The Sarns Venous Return Catheters with Duraflo® Treatment perform as intended according to their performance specifications. The Sarns Venous Return Catheters with Duraflo® Treatment are substantially equivalent to their predicate devices.
Page 116 of 178
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three faces in profile, representing the department's mission to protect the health of all Americans.
JUN 18 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jason Smith Requlatory Affairs Coordinator 3M Health Care Cardiovascular Systems Sarns and CDI Products ............ 6200 Jackson Road Ann Arbor, Michigan 48103-9300
Re: * K964374 Sarns Venous Return Catheters with Duraflo® Treatment Requlatory 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, Drug, 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 reqistration, 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 Requlations, 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 regulatory action. In addition, FDA may publish further announcements 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.
4
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 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" (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, Ph.D.
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K 944/3 74
Device Name: Sarns Venous Return Catheters with Duraflo Treatment
Indications For Use:
The Sarns Standard Venous Return Catheters with Duraflo Treatment and the Sarns Right Angle Venous Return Catheters with Duraflo Treatment ~ are indicated for use in dual cannulation of the superior and inferior vena cava for venous drainage during cardiopulmonary bypass surgery.
The Sarns Two Stage Venous Return Catheters with Duraflo Treatment, Venoatrial Catheters with Duraflo Treatment, and the Dual Stage Venous Return Catheters with Duraflo Treatment are indicated for use in single tube drainage of the right atrium and vena cava during cardio pulmonary bypass surgery.
Page 1 of 178
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| (1.e., 510(k) Number) | K964374 |
| Division of Cardiovascular and Respiratory Devices | |
| 510(k) Number |
| Prescription Use ✓
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| --------------------------------------------------------------------------------------------- | ---- | ----------------------------- |
(Optional Format 1-2-96)