(36 days)
The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
The InScope Precision Balloon Dilator is a sterile, single use, disposable esophageal dilator. The InScope Precision Balloon Dilator contains three marking bands on the balloon to facilitate more precise centering the balloon within the stricture. The middle band is located at the center of the balloon at 5 cm distance from the shaft marker. The proximal and distal bands are set 2.5 cm from the centre band. The InScope Precision Balloon Dilator is provided with a stopcock to maintain pressure or vacuum. The InScope Precision Balloon Dilator is capable of 3 distinct and progressive larger diameters as a function of the applied inflation pressure. The specific pressure / diameter relationship is represented on the labeling of each product. The subject InScope Precision Balloon Dilator described in this submission is virtually identical to its predicate device (Boston Scientific's CRE Balloon dilatation catheter), which already has received FDA 510(k) concurrence.
This document is a 510(k) Pre-market Notification for the InScope Precision Balloon Dilator, seeking substantial equivalence to a predicate device. As such, it does not contain acceptance criteria in the traditional sense of a performance study with numerical targets for sensitivity, specificity, etc. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics and non-clinical bench testing.
Here's an analysis based on the provided text, addressing the points you requested where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, no explicit acceptance criteria with quantitative targets are provided in the document. The "performance" is assessed through comparison to a predicate device and non-clinical bench tests.
| Feature / Characteristic | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Materials | Substantially equivalent to predicate device (Boston Scientific's CRE Balloon dilatation catheter) | Found to be biocompatible; technological characteristics considered substantially equivalent. |
| Mode of Operation | Substantially equivalent to predicate device | Technological characteristics considered substantially equivalent. |
| Performance Properties | Substantially equivalent to predicate device | Demonstrated via data collected from non-clinical bench type tests and analyses. |
| Biocompatibility | Meets biocompatibility standards | Materials used are found to be biocompatible. |
| Sterilization | Substantially equivalent to predicate device | Technological characteristics considered substantially equivalent. |
| Packaging | Substantially equivalent to predicate device | Technological characteristics considered substantially equivalent. |
| Inflation Pressure/Diameter Relationship | Specific relationship, represented on labeling | Capable of 3 distinct and progressive larger diameters as a function of applied inflation pressure. Specific relationship represented on labeling. |
| Marking Bands | Provide precise centering facilitation | Contains three marking bands on the balloon to facilitate more precise centering within the stricture. (Middle band at center, 5 cm from shaft marker; proximal and distal bands 2.5 cm from center band.) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: This document refers to "non-clinical bench type tests and analyses." It does not specify a sample size for these tests.
- Data Provenance: The document does not specify country of origin for the data, nor whether it was retrospective or prospective. Given it's non-clinical bench testing, these distinctions (retrospective/prospective) are less applicable than for clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable or not specified. Bench testing typically relies on predefined physical or engineering standards, not expert clinical interpretation of test results in the same way clinical ground truth is established.
- Qualifications of Experts: Not applicable or not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. For non-clinical bench testing, results are typically determined by measurement against established standards, not through adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This submission is for a device, an esophageal dilator, not an AI/imaging diagnostic tool that would typically involve a multi-reader study. The evaluation focuses on the safety and effectiveness of the device itself, primarily through bench testing and comparison to a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. This device is an esophageal dilator, not an algorithm.
7. The Type of Ground Truth Used
- Ground Truth: For non-clinical bench tests, "ground truth" refers to established engineering specifications, physical measurements, and materials science standards. The document states "materials used in the subject device are found to be biocompatible," implying adherence to biocompatibility standards. The functional aspects like "3 distinct and progressive larger diameters as a function of the applied inflation pressure" would be verified against engineering specifications and measured outcomes.
8. The Sample Size for the Training Set
- Not applicable. This document describes a medical device (dilator), not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set for an AI model is involved.
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Appendix B
| 510 (k) Summary of Safety and Effectiveness | |
|---|---|
| Submitter'sname andaddress | Cordis Europa, NVOosteinde 8NL-9301 LJ RodenThe Netherlands |
| ContactPerson | Harm HovingaSenior Regulatory Affairs AssociateTel: +31 - (5050) 22479Fax: +31 - (5050) 22456E-mail: hhovinga@crdnl.jnj.com) |
| Date prepared | December 23, 2004 |
| Device TradeName | InScope Precision balloon Dilator |
| CommonName | Esophageal dilator |
| ClassificationName | KNQ (21 CFR 876.5365 Esophageal dilator |
| DeviceClassification | Class II. |
| Performancestandards | FDA has not (yet) established specific performance standards for this deviceunder section 514 of the Food, Drug and Cosmetic Act. |
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| ProductDescription | The InScope Precision Balloon Dilator is a sterile, single use, disposableesophageal dilator. The InScope Precision Balloon Dilator contains threemarking bands on the balloon to facilitate more precise centering the balloonwithin the stricture. The middle band is located at the center of the balloon at5 cm distance from the shaft marker. The proximal and distal bands are set2.5 cm from the centre band. The InScope Precision Balloon Dilator isprovided with a stopcock to maintain pressure or vacuum. The InScopePrecision Balloon Dilator is capable of 3 distinct and progressive largerdiameters as a function of the applied inflation pressure. The specific pressure/ diameter relationship is represented on the labeling of each product.The subject InScope Precision Balloon Dilator described in this submission isvirtually identical to its predicate device (Boston Scientific's CRE Balloondilatation catheter), which already has received FDA 510(k) concurrence. |
|---|---|
| Intended Use | The InScope™ Precision Balloon Dilator is intended for use in adult andadolescent populations to endoscopically dilate strictures of the esophagus. |
| Technologicalcomparison | Comparisons of the subject and the predicate device(s) show thattechnological characteristics, such as materials, mode of operation,performance properties, biocompatibility, sterilization and packaging areconsidered substantially equivalent to the currently marketed predicatedevices, |
| PerformanceData | The safety and effectiveness of the InScope Precision Balloon Dilator hasbeen demonstrated via data collected from non-clinical bench type tests andanalyses. The materials used in the subject device are found to bebiocompatible. |
Substantial Equivalence Statement
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from Johnson compan
A statement of substantial equivalence to another product is required by 21 CFR 807.87 and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any I ne present submission interpreted as an admission or used as evidence in patcht and is not to be interpt. As the commissioner of the FDA stated: a patche mirringencere lastantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The determination is not intended to have any bearing whatsoever on the deter infringement suits." 42 Federal Register 42, 50 et seq. (1977).
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FEB - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Harm Hovinga Senior Regulatory Affairs Associate Cordis Corporation, A Johnson & Johnson Company Cordis Europa N.V. Oosteinde 8 9301 LJ Roden, Drenthe THE NETHERLANDS
Re: K043605
Trade/Device Name: InScope" Precision Balloon Dilator Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: 78 KNO Dated: December 23, 2004 Received: December 30, 2004
Dear Mr. Hovinga:
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 Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/dsmadsmam.html
Sincerely vours.
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
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Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement
Page 1 of 1 Effective Date: 11/15/00
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Appendix A: Intended Use Statement
Page 1 of 1
510(k) Number (if known): K043605
Device Name:
InScope™ Precision Balloon Dilator
Indications for Use Statement
The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | ----------------------------------------------------- | ---- | ---------------------- |
| (Division Sign-Off) | Nancy C Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K043605 |
§ 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.