(88 days)
The Modified CRE™ Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label.
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The provided text describes a 510(k) premarket notification for a medical device, the Modified CRE™ Balloon Dilatation Catheter. However, it does not include detailed information regarding specific acceptance criteria, a dedicated study proving performance against those criteria, or the specific elements requested in your prompt (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance).
The document focuses on establishing substantial equivalence to previously marketed devices based on descriptive, technological, and general performance characteristics.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
Acceptance Criteria and Study for Modified CRE™ Balloon Dilatation Catheter (K974788)
The submitted 510(k) summary and associated letter discuss the substantial equivalence of the Modified CRE™ Balloon Dilatation Catheter. The documentation focuses on demonstrating that the new device is as safe and effective as predicate devices through laboratory testing and biocompatibility assessments, rather than presenting a study with specific acceptance criteria and performance metrics in the format requested.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in the document as specific, quantitative acceptance criteria. The document generally states that "laboratory testing regarding characteristics was performed... to verify its safety and performance." | Laboratory testing satisfied: "Laboratory testing regarding characteristics was performed on the Modified CRE™ Balloon Dilatation Catheter to verify its safety and performance." Biocompatibility in compliance: "A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified CRE™ Balloon Dilatation Catheter with satisfactory results." Conclusion of substantial equivalence: "Boston Scientific Corporation believes that Modified CRETM Balloon Dilatation Cathetere is substantially equivalent to the current CRE™ Balloon Dilatation Catheter and the Vector TTSTM Balloon Dilatation Catheter." |
Explanation: The documentation does not provide quantitative or specific performance metrics or acceptance criteria typically seen in clinical studies for AI/software devices. Instead, it relies on a qualitative statement that "laboratory testing... verified its safety and performance" and "biocompatibility assessment... with satisfactory results." The primary "acceptance" is the FDA's determination of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified. The document refers to "laboratory testing" and "biocompatibility assessment" but does not give details about the number of devices tested, the duration, or the context of these tests (e.g., in vitro, ex vivo, or animal studies).
- Data Provenance: Not specified. The nature of the "laboratory testing" and "biocompatibility assessment" implies internal testing conducted by Boston Scientific Corporation, likely in a controlled laboratory environment. No country of origin or retrospective/prospective nature of data for a "test set" is mentioned, as this is not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided in the document. The device is a physical medical device (balloon dilatation catheter), not an AI/software device that requires expert-established ground truth from images or other data for performance evaluation. The "ground truth" for this device would be its mechanical and material properties meeting design specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical trials or studies involving expert review of data for AI/software evaluations, which is not the context 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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision support systems. The Modified CRE™ Balloon Dilatation Catheter is a physical therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This concept is specific to AI/software algorithms. The performance of this physical device is evaluated via laboratory testing of its physical properties and biocompatibility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The concept of "ground truth" as typically applied to AI/software evaluation (e.g., expert consensus, pathology) is not applicable here. The "ground truth" for this device would be its adherence to established engineering standards, material specifications, and biological safety requirements, verified through standard laboratory tests and assessments.
8. The sample size for the training set
- Not applicable / Not provided. This device is a physical product, not an AI/software system that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable / Not provided. This information pertains to AI/software development, which is not the subject of this 510(k) submission.
Summary of Device Performance and Basis for Substantial Equivalence:
The core of the 510(k) submission for the Modified CRE™ Balloon Dilatation Catheter is the demonstration of substantial equivalence to existing, legally marketed predicate devices (current CRE™ Balloon Dilatation Catheter and Vector TTS™ Balloon Dilatation Catheter).
The justification for substantial equivalence is based on:
- Descriptive and Technological Characteristics: The device is considered substantially equivalent in its design and technology to the predicate devices.
- Performance Characteristics (Laboratory Testing): In-house laboratory testing was conducted to "verify its safety and performance." While no specific quantifiable results are given, the conclusion is that these tests were satisfactory.
- Biocompatibility Assessment: An assessment of patient- and fluid-contact materials was performed, yielding "satisfactory results."
- Packaging, Sterilization, and Pyrogenicity: These aspects were addressed, with the device being sterilized using ethylene oxide gas per AAMI protocol and pyrogenicity testing deemed unnecessary due to typical non-blood contact.
The FDA's letter confirms that they "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This determination is the "acceptance" that allows the device to be marketed.
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MAR 2 0 1998
510(K) SUMMARY
FOI RELEASABLE
Pursuant to § 513(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Prematket Notification " ... 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.
Common/Usual Names: Balloon Dilatation Catheter
TRADE/PROPRIETARY NAME: Modified CRE™ Balloon Dilatation Catherer
| ➤ CLASSIFICATION NAME &DEVICE CLASSIFICATION: | |||
|---|---|---|---|
| Class II | |||
| Name | Number | 21 CFR Re | |
| Dilator, Esophageal | 78 KNQ | 876.5365 | |
| Endoscope & Accessories | 78 KOG | 878.1500 | |
| ➤ DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| ➤ OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Owner/Operator No. 9912058 | |||
| ➤ CONTACT PERSON: | Daniel J. Dillon, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Modificd CRE™ Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label.
CONTRAINDICATIONS
None known.
POTENTIAL COMPLICATIONS
Possible complications that may result from an alimentary tract procedure include, but may not be limited to; perforation; hemorrhage; hematoma; septicemia/infection; allergic reaction to contrast medium.
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1974788 1202
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Modified CRE™ Balloon Dilatation Catheter is substannally equivalent to the current CRE™ Balloon Dilatation Catheter and the Vector TTS™ Balloon Dilatation Catheter.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on the Modified CRE™ Balloon Dilatation Catheter to verify its safety and performance. A biocompatibility assessment was performed on the patientand fluid-contact materials of the Modified CRE™ Balloon Dilatation Catheter with satisfactory results.
PACKAGING, STERILIZATION, AND PYROGENICITY
The Modified CRETM Balloon Dilation Cather will be packaged both sterile and non-sterile in a Tyvek-Mylar pouch. The Modified CRETM Balloon Dilatation Catheter, when sterilized, will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Because the Modified CRE™ Balloon Dilatation Catheter will not normally contact blood, pyrogenicity testing will not be performed.
CONCLUSION
Boston Scientific Corporation believes that Modified CRETM Balloon Dilatation Cathere is substantially equivalent to the current CRE™ Balloon Dilatation Catheter and the Vector TTSTM Balloon Dilatation Catheter. Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Modified CRE™ Balloon Dilatation Catheter will meet the minimum requirements that are considered acceptable for its intended use.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with three heads, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 20 1998
Mr. Daniel J. Dillon Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K974788 Modified CRE™ Balloon Dilatation Catheter Dated: December 19, 1997 Received: December 22, 1997 Regulatory Class: II 21 CFR 876.1500/Procode: 78 KOG 21 CFR 876.5365/Procode: 78 KNQ
Dear Mr. Dillon:
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 registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration.
If your device is classified (see above) into either class II (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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 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) 594-4613. 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 "http://www.fda.gov/cdrf/dsmaldsmamain.html".
Sincerely yours
Lillian Yin Ph D
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Device Name: Modified Balloon Dilatation Catheter
Indication for Use:
The Modified Balloon Dilatation Catheters are indicated for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract. The recommended application is printed on the package label.*
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- The recommended application on the label may refer to any combination of esophageal, pyloric, and colonic dilatation.
Image /page/3/Figure/6 description: The image contains a thick, dark line that extends diagonally across the frame. The line starts from the upper-left corner and descends towards the lower-right corner. The background is plain white, which makes the dark line stand out prominently.
- The recommended application on the label may refer to any combination of esophageal, pyloric, and colonic dilatation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Ratting /
(Division Sign-Off)
eproductive, Abdominal, ENT.
510(k) Number K974588
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.