The Biosensors Embolectomy Catheter is indicated for use in the removal of emboli and thrombi from the arterial system. The catheter should be used only by a physician with surgical skill in the vascular system.

Device Description

Biosensors International (BI) has developed an embolectomy catheter that is equivalent in design and performance to embolectomy catheters currently marketed by Baxter. BSI's embolectorny catheters are configured as single lumen, balloon-tipped catheters.

The catheters vary in length and diameter to accommodate various thrombotic obstruction and vessel lumen sizes. They are supplied in 3, 4, 5, 6, and 7 French diameters, with inflated balloon diameters of 6, 9, 11, 13, and 14 mm, respectively.

The catheters are color coded, and have black distance markings at 10 cm intervals (with "0" cm located at the distal catheter tip.)

The proximal end of the flexible catheters terminate in a rigid, winged adapter with female luer lock port to permit attachment to a stylet for stiffening the catheter during insertion, or sterile syringe during balloon inflation. The distal end of the catheters terminate in a latex-coated tip immediately distal to the latex balloons. The latex balloons lie flat against the catheters during insertion through the vasculature and lesion, and are inflated with sterile isotonic saline or other appropriate sterile solution during embolectomy procedures.

The catheters are supplied with a stainless steel stylet inserted in their lumens. The stylets terminate proximally in a rigid male luer adapter that mates with the female luer of the catheters. The stylets can be used, when appropriate, to add rigidity to the catheters to aid in their insertion.

AI/ML Overview

The Biosensors Embolectomy Catheter received 510(k) clearance based on its substantial equivalence to the Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter. The device's performance was assessed through a series of tests to demonstrate it met the acceptance criteria implied by its substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance
Material Biocompatibility: Materials are biocompatible for short-term blood exposure.	Identical to those used for other Biosensors catheters exposed to circulating blood for a short period.
Burst Strength of Balloon: Maintains integrity under inflation.	Test data collected (specific values not provided, but deemed satisfactory).
Pull Strength of Balloon: Maintains attachment to catheter.	Test data collected (specific values not provided, but deemed satisfactory).
Balloon Inflation Volume Accuracy: Inflates to expected volume.	Test data collected (specific values not provided, but deemed satisfactory).
Tensile Strength of Catheter: Withstands forces during use.	Test data collected (specific values not provided, but deemed satisfactory).
Leak Test Data: Catheter and balloon system prevents fluid leakage.	Test data collected (specific values not provided, but deemed satisfactory).

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each specific test (burst strength, pull strength, etc.). The study appears to be a retrospective comparison based on laboratory testing of the Biosensors Embolectomy Catheter against the characteristics of the predicate device. There is no indication of country of origin for the data provided, as it is a premarket notification for a US market.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. For a medical device like an embolectomy catheter, the "ground truth" for performance evaluations typically comes from engineering testing against established standards and benchmarks of predicate devices, rather than expert consensus on a test set of clinical images or cases.

4. Adjudication Method for the Test Set:

This information is not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers are interpreting data or making diagnoses, often for image-based diagnostic devices. This premarket notification focuses on the physical and material performance of the catheter.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. This type of study involves human readers and is not relevant for the assessment of a physical medical device like an embolectomy catheter.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance assessment was conducted in the sense that the device's physical and material properties were tested in a laboratory setting. This is an "algorithm only" equivalent in that the device's performance characteristics were evaluated as an isolated entity. The device's performance in terms of burst strength, pull strength, inflation volume accuracy, tensile strength, and leak resistance were evaluated independently.

7. Type of Ground Truth Used:

The "ground truth" for this study was based on engineering and performance specifications established for similar medical devices, specifically the predicate Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter. It relies on the understanding that if the new device performs equivalently to a legally marketed predicate device on these objective measures, it is deemed safe and effective.

8. Sample Size for the Training Set:

This information is not applicable as this is a physical medical device, not an AI/algorithm-driven device requiring a training set in the conventional machine learning sense. The "training" for such a device would be the design and manufacturing process, optimized through engineering principles.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the same reasons as #8. The "ground truth" relevant to the device's development would be established through industry standards, regulatory requirements, and the functional specifications of existing, successful embolectomy catheters.

Summary

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K973477

BIOSENSORS EMBOLECTOMY CATHETER PREMARKET NOTIFICATION

510K SUMMARY Prepared: August 11, 1997

1. Submitted by:

John Shulze Sunscope International, Inc. 20250 Acacia St., Suite 115 Newport Beach, CA 92660 Tel: (714) 553-8300 Fax: (714) 553-9129

2. Contact Person:

John Shulze

3. Device Identification:

Trade Name: Biosensors Embolectomy Catheter Common Name: Embolectomy Catheter Classification Name: Catheter, Embolectomy

4. Predicate Device(s):

Baxter Healthcare's Fogarty® Arterial Embolectomy Catheter

5. Device Description:

The catheters are color coded, and have black distance markings at 10 cm intervals (with "0" cm located at the distal catheter tip.)

The catheters are supplied with a stainless steel stylet inserted in their lumens. The stylets terminate proximally in a rigid male luer adapter that mates with the female luer

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BIOSENSORS EMBOLECTOMY CATHETER PREMARKET NOTIFICATION

of the catheters. The stylets can be used, when appropriate, to add rigidity to the catheters to aid in their insertion.

6. Intended Use:

7. Summary of Technological Characteristics of Device in relation to Predicate Device(s):

The design of the Biosensors 3 through 7 Fr. embolectomy catheters is identical to that of the predicate devices. All of the catheter tips (3-7 Fr.) are latex-coated to minimize the potential for vessel trauma during catheter insertion. Both the Biosensors and Baxter 3 French embolectomy catheters terminate in a latex-coated spring tip.

Inflatable latex balloons are affixed at the distal tips of the Biosensors and Baxter catheters, which are inflated with an appropriate sterile liquid during embolectomy procedures. Placement of distance markings on the catheters are identical. The proximal ends of the flexible catheters terminate in rigid, winged adapters with female luer ports to provide for attachment to an inflation syringe.

8. Assessment of Performance Data used to justify Substantial Equivalence Claim

Biosensors International has developed an embolectomy catheter that is substantially equivalent in function to the predicate Baxter embolectomy catheters. The materials used in the fabrication of Biosensors embolectomy catheters are identical to those used for other Biosensors catheters which also are exposed to circulating blood for a short period of time, and, therefore have identical biocompatibility requirements as the embolectomy catheters.

Further, test data collected on the burst and pull strength of the balloon, balloon inflation volume accuracy, tensile strength of the catheter, and leak test data demonstrate that Biosensors International Embolectomy Catheters' performance is substantially equivalent to that of the predicate devices, and no new questions concerning safety and efficacy are raised.

9. Conclusion:

Based on the test data gathered, Biosensors International Embolectomy Catheters are substantially equivalent to Baxter Healthcare's embolectomy catheters.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines forming a profile. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the upper portion of the circle. The text is in all capital letters and is evenly spaced around the curve.

ದಿದ್ದಾರೆ.
ವಿದ್ಯಾರಿ ಮಾರ್ಥಿಕಾರಿ ಮಾಡಿ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಥಿಕ ಮಾರ್ಕಾರಿ ಮಾರ್ಕಾರಿ 4 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John E. Shulze Directing Manager Sunscope International Inc. 20250 Acacia Street, Suite 115 Newport Beach, CA 92660

K973477 Re : Trade Name: Biosensors Embolectomy Catheter Requlatory Class: II Product Code: DXE Dated: June 8, 1998 Received: June 9, 1998

Dear Mr. Shulze:

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 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). 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to -A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

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Page 2 - Mr. John E. Shulze

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.

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) 594-4586. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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 "http://www.fda.gov/cdrh/dsma/dsmamain.html".

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

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of Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name: BIOSENSORS EMBOLECTOMY CATHETER

Indications For Use:

Proscription Use .. Proscription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------

Judith Danielson for Doyle Gantt

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_ K 973477

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).