(186 days)
Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The proposed Ultra-Thin SDS Balloon Dilatation Catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the 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.
This document is a 510(k) premarket notification for a medical device called the "Ultra-Thin SDS Balloon Dilatation Catheter". It is a submission to the FDA seeking clearance to market the device by demonstrating its substantial equivalence to a legally marketed predicate device.
Let's break down the requested information:
1. Table of Acceptance Criteria & Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria with numerical targets or a "reported device performance" against those criteria in a tabular format as would be typical for clinical studies or performance testing summaries. Instead, it makes a general statement of compliance.
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Acceptance Criteria (Implicit): Assumed to be "conformance to the requirements for its intended use" and "no new safety or performance issues."
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Reported Device Performance:
"Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen."Therefore, a table cannot be constructed with the provided information. The document confirms that testing was done and that the device met the requirements without new issues, but not specific numeric results or thresholds.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "Bench testing and biocompatibility testing" but does not give any details on the number of devices or samples tested.
- Data Provenance: The testing was "performed to support a determination of substantial equivalence." This refers to internal testing conducted by the manufacturer, Boston Scientific Corporation, based in Galway, Ireland. The testing is likely retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. This document describes a 510(k) submission primarily based on bench and biocompatibility testing, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set:
- Not applicable / Not specified. As this document does not describe a clinical study requiring expert adjudication of results, this information is not relevant.
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. This document describes a medical device (a balloon dilatation catheter), not an AI algorithm. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This document describes a medical device (a balloon dilatation catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used:
- Not applicable for clinical ground truth. For the bench and biocompatibility testing, the "ground truth" would be established by specifications and regulatory standards for material properties, mechanical performance (e.g., burst pressure, fatigue), and biological safety.
8. The sample size for the training set:
- Not applicable / Not specified. This is a medical device (catheter) submission, not an AI model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As above, there is no "training set." The performance of the device is assessed against engineering specifications and biocompatibility standards.
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Ultra-Thin SDS Balloon Dilatation Catheter
ATTACHMENT H
DEC 21 2001
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 oorporation onooooo to Sabmit a US/13((1)(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 Ultra-Thin SDS Balloon Dilatation Catheter is as follows:
| Trade Name: | Ultra-Thin SDS Balloon Dilatation Catheter |
|---|---|
| Manufacturer: | Boston Scientific CorporationBallybrit Business ParkGalway, Ireland |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug andCosmetic Act, the device classification is Class II,Performance Standards. |
| Predicate Devices: | The following device is referenced in this premarketnotification as the predicate device for the Ultra-Thin SDSBalloon Dilatation Catheter:Boston Scientific Corporation -- Marshal (submitted asCourier ST) Balloon Dilatation Catheter (K972744)The device mentioned above has been determinedsubstantially equivalent by FDA. |
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Ultra-Thiri SDS Balloon Dilatation Catheter
| Device Description: | The proposed Ultra-Thin SDS Balloon Dilatation Catheter isan over-the-wire catheter indicated for percutaneoustransluminal angioplasty of the iliac, femoral, ilio-femoral,popliteal, renal arteries and for the treatment of obstructivelesions of native or synthetic arteriovenous dialysis fistulae.The proposed device is designed to be placed overguidewires which have outer diameters of .035" or smaller. |
|---|---|
| --------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Ultra-Thin SDS Balloon Dilatation Catheters are Indications for Use: recommended for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Safety and Performance: Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing regimen.
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the Ultra-Thin SDS 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2001
Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K011889
Trade Name: Ultra-Thin SDS Balloon Dilatation PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Transluminal Balloon Dilatation Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 26, 2001 Received: September 28, 2001
Dear Ms. Bolton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the excreations of the enactment date of the Medical Device Amendments, or to conmise of the to 112) 2011-07-12 in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may , answer 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, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Jennifer Bolton, RAC
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 issumes of a basements with other requirements of the Act that I DA has inado a determinations administered by other Federal agencies. You must of any I ecolar statutes and regulations and limited to: registration and listing (21 Comply with an the rice orequirements) and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections (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) I his ictier will anow you to ough maing of substantial equivalence of your device to a legally premaince hotification. The Price is 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 If you desire speonne au roo for you in vitro diagnostic devices), please contact the Office of additionally 21 CLTC at 007.10 for in Trace visitions on the promotion and advertising of Compliance at (301) 597 1010. The Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation childed, "Nilocranians on your responsibilities under the Act may be obtained from the Other general information on your responsional 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/dsma/dsmamain.html
Sincerely yours,
Dale Tell
ram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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New Application 510(k) Number (if known):
Ultra-Thin SDS Balloon Dilatation Catheter Device Name:
Indications for Use:
Ultra-Thin SDS Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the illio-femoral, popliteal, renal arteries and for translaninal angloplace of the illus, it native or synthetic arteriovenous dialysis fistulae.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011889
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).