(162 days)
Ultra-Thin SDS Balloon Dilatation Catheters are indicated for stent deployement/optimization of the J&J Palmaz® Biliary Storit and for the treatment of obstructive lesions of biliary strictures.
an over-the-wire catheter designed to be placed over an over the which have outer diameters of .035" or smaller.
The provided document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of device performance metrics like accuracy, sensitivity, or specificity, which would typically be found in studies for AI/software devices. This document describes a medical device, the Ultra-Thin SDS Balloon Dilatation Catheter, and its 510(k) premarket notification process for substantial equivalence to a predicate device.
Instead, the document focuses on:
- Substantial Equivalence: The primary "acceptance criteria" and "study" are related to demonstrating substantial equivalence to a legally marketed predicate device (Boston Scientific Corporation -- Marshal Balloon Dilatation Catheter, K973008) in accordance with FDA regulations.
- Bench Testing and Biocompatibility: The "study" performed involved "Functional and integrity bench testing and biocompatibility" according to FDA guidance (ODE Blue Book Memorandum #G95-1, May 1, 1995) and ISO-10993 standards. The data from these tests "supported the substantial equivalence."
Given the nature of the provided text, I cannot provide an answer that directly addresses the specific requested points related to AI/software device performance criteria such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. These types of studies are not described in the provided 510(k) summary for this balloon dilatation catheter.
Summary of available information related to acceptance criteria and "study":
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K973008) | Achieved, based on "Functional and integrity bench testing and biocompatibility." |
| Safety and Effectiveness for Intended Use | "Shown to be safe and effective for its intended use" based on "Indication for Use, technological characteristics and safety and performance testing." |
| Compliance with Regulatory Standards (e.g., FDA, ISO-10993) | Testing performed in accordance with ODE Blue Book Memorandum #G95-1 and ISO-10993. |
2. Sample size used for the test set and the data provenance: Not applicable/not defined in the provided document, as the "study" primarily involved bench testing and biocompatibility assessments, not clinical or image-based test sets with associated data provenance in the context of AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not defined. Ground truth in this context would relate to physical and biological properties assessed through testing, not expert interpretation of data.
4. Adjudication method for the test set: Not applicable/not defined. Adjudication methods are relevant for subjective interpretations, which are not described here.
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: Not applicable. This device is a physical medical instrument (balloon catheter), not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument (balloon catheter), not an AI system. Its performance is inherent to its physical properties and function.
7. The type of ground truth used: For functional and integrity bench testing, the "ground truth" would be established by validated measurement standards and physical/material properties. For biocompatibility, it would be compliance with biological safety standards through specific assays.
8. The sample size for the training set: Not applicable. This device is a physical medical instrument (balloon catheter), not an AI system that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
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June 14, 2001
ATTACHMENT H
Kol 1909
NOV 2 8 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 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 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 premarket notification as the predicate device for the Ultra-Thin SDS Balloon Dilatation Catheter:Boston Scientific Corporation -- Marshal Balloon Dilatation Catheter (K973008)The device mentioned above has been determined substantially equivalent by FDA. |
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Ultra-Thin SDS Balloon Dilatation Catheter
June 14, 2001 K611909
- The proposed Ultra-Thin SDS Balloon Dilatation Catheter is Device Description: an over-the-wire catheter designed to be placed over an over the which have outer diameters of .035" or smaller.
- Ultra-Thin SDS Balloon Dilatation Catheters are indicated for Indications for Use: stent deployement/optimization of the J&J Palmaz® Biliary Storit and for the treatment of obstructive lesions of biliary strictures.
- Safety and Performance: Functional and integrity bench testing and biocompatibility r unctional and integrity befon guidance document, ODE Blue Book Memorandum #G95-1, May 1, 1995, Use of Dook Morneraliand ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" were performed, and the data supported the substantial equivalence of the Ultra-Thin SDS Balloon Dilatation Catheter to the Marshal Balloon Dilatation Catheter.
- Based on the Indication for Use, technological Conclusion: 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 8 2001
Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K011909
Trade/Device Name: Ultra-Thin SDS Balloon Dilatation Catheter for the Deployment/Optimization of the Johnson & Johnson Palmaz® Biliary Stent
Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: Class II Product Code: FGE 78 Dated: October 2, 2001 Received: October 3, 2001
Dear Ms. Bolton:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 nredicate device results in a classification for your device and thus, permits your device to
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
proceed to the market.
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510(k) Number (if known):
New Application K011909
Device Name:
Ultra-Thin SDS Balloon Dilatation Catheter
Indications for Use:
Ultra-Thin SDS Balloon Dilatation Catheters are indicated for stent Ultra-Thin SUS Balloon Dilatation Oatherore are Marculo Palmaz® Billiary Stent and for the treatment of biliary strictures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
く
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011909
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.