The SC 35 Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the SC 35 Balloon Dilatation Catheter, and details the in vitro functional and biocompatibility tests performed to demonstrate its safety and performance. However, it does not contain information about a clinical study involving human patients or a comparative effectiveness study with AI assistance.

Here's a breakdown based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance / Outcome (Implicit)
In Vitro Functional Tests	Balloon Burst Testing	Met criteria for safety and performance
	Multiple Inflation Testing	Met criteria for safety and performance
	Inflation/Deflation Time Testing	Met criteria for safety and performance
	Balloon Compliance Testing	Met criteria for safety and performance
	Balloon Proximal Bond Testing	Met criteria for safety and performance
	Sheath Withdrawal Testing	Met criteria for safety and performance
	Wingfolded Balloon Profile Testing	Met criteria for safety and performance
	Coating Coefficient of Friction Testing	Met criteria for safety and performance
	Particulate Analysis Testing	Met criteria for safety and performance
	Solvent Residual Testing	Met criteria for safety and performance
Biocompatibility Tests	Cytotoxicity	Met criteria for safety and performance
	Hemolysis	Met criteria for safety and performance
	Acute Intracutaneous Reactivity	Met criteria for safety and performance
	Acute Systemic Toxicity	Met criteria for safety and performance
	Sensitization	Met criteria for safety and performance
	Pyrogenicity	Met criteria for safety and performance

Note: The document states "Based on...safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use," implying all listed tests met their predefined acceptance criteria, though the specific quantitative criteria and results are not provided.

Regarding the study proving the device meets the acceptance criteria:

The "study" referenced in the document is a series of in vitro functional tests and biocompatibility tests, not a clinical study involving human subjects or AI.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not specified. The document only lists the types of in vitro and biocompatibility tests performed.
Data Provenance: The tests were performed by the manufacturer, Boston Scientific Corporation, based in Natick, MA, USA. The data would be considered prospective, as it was generated specifically for the premarket notification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a physical medical instrument, and the testing described consists of laboratory-based physical and chemical tests rather than interpretation of diagnostic data by experts for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As these are laboratory tests, there is no expert adjudication process in the sense of reviewing diagnostic outcomes. Test results would be compared against predefined engineering and biological specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not performed. The device is a physical balloon dilatation catheter, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm-based device. The "performance" described is the physical and biological characteristics of the catheter itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Engineering Specifications and Biocompatibility Standards: The "ground truth" for the in vitro tests would be the established performance specifications for balloon catheters (e.g., maximum burst pressure, inflation/deflation times, material properties) and regulatory standards for biocompatibility (e.g., ISO standards for medical devices).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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SC 35 Balloon Dilatation Catheter

K993305

September 23, 1999

ATTACHMENT H

SUMMARY OF SAFETY AND EFFECTIVENESS

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects..."

The summary regarding the adverse health effects of the proposed SC 35 Balloon Dilatation Catheter is as follows: र्

Trade Name:	SC 35 Balloon Dilatation Catheter
Manufacturer:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760
Device Generic Name:	Balloon Dilatation Catheter
Classification:	According to Section 13 of the Federal Food, Drug and Cosmetic Act, thedevice classification is Class II, Performance Standards.
Predicate Devices:	The following devices are referenced in this premarket notification aspredicate devices for the SC 35 Balloon Dilatation Catheter:Boston Scientific Corporation - Ultra-thin DiamondTM Balloon DilatationCatheterBoston Scientific Corporation - Courier STTM Balloon Dilatation CatheterAll of the devices mentioned above have been determined substantiallyequivalent by FDA.
Device Description:	The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheterindicated for percutaneous transluminal angioplasty of the iliac, femoral,ilio-femoral, popliteal, infrapopliteal, renal arteries and for treatment ofobstructive lesions of native or synthetic arteriovenous dialysis fistulae. Theproposed device is designed to be placed over guidewires which haveouter diameters of .035" or smaller.

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SC 35 Balloon Dilatation Catheter

September 23, 1999

Indications for Use:

Safety and Performance:

The following in vitro functional tests were performed on the SC 35 Balloon Dilatation Catheter:

Balloon Burst Testing
. Multiple Inflation Testing
. Inflation/Deflation Time Testing
Balloon Compliance Testing .
. Balloon Proximal Bond Testing
. Sheath Withdrawal Testing
Wingfolded Balloon Profile Testing .
Coating Coefficient of Friction Testing ●
. Particulate Analysis Testing
. Solvent Residual Testing

The following biocompatibility tests were performed:

Cytotoxicity .
. Hemolysis
. Acute Intracutaneous Reactivity
. Acute Systemic Toxicity
. Sensitization
. Pyrogenicity

Conclusion:

Based on the Indication for Use, technological characteristics and safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

APR 1 0 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Terry A. McGovern Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537

K993305 Re: Semi Compliant (SC) 35 Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT Dated: January 12, 2000 Received: January 18, 2000

Dear Ms. McGovern:

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 The general controls provisions of the Act provisions of the Act. include requirements for annual registration, listing of devices, qood 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 Regulations, 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 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.

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Page 2 - Ms. Terry A. McGovern

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 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,

Chitophem. Ahtor

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

New Application

Device Name:

Semi-Compliant 35 Balloon Dilatation Catheter

The Semi-Compliant 35 Balloon Dilitation Indications for Use: Catheter is indicated for percutaneous transluminal angioplasty of the iliac, femoral, illio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chitophth for Dillard

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K993305

Prescription Use / Use (Per 21 CRF 801.109)

Over-The-Counter

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).