(64 days)
The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded 0.035" guide wire - Is a sterile, single use, disposable dilator used in the alimentary tract (esophagus, pylorus and colon). In the sterile product packaging also a stopcock is provided to maintain pressure or vacuum by an inflation device. The balloon specific pressure / diameter relationship is represented on the labeling of each product.
The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).
The subject InScope Precision Balloon Dilator - Wire Guided described in this submission is virtually identical to its predicate device(s), which already have received 510(k) concurrence.
Compared to the previously cleared predicate device - InScope Precision Balloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator - Wire Guided in this submission now resembles the Boston Scientific's CRE Wireguided Balloon Dilator, which already received FDA 510(k) concurrence.
The provided text is related to a 510(k) premarket notification for the "InScope™ Precision Balloon Dilator - Wire Guided." This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
However, the document does not contain information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about a standalone algorithm, human-in-the-loop performance, expert consensus, training set, or ground truth establishment.
Instead, the document focuses on:
- Substantial Equivalence: The primary assertion is that the InScope™ Precision Balloon Dilator - Wire Guided is "virtually identical" and "substantially equivalent" to its predicate device(s) that have already received 510(k) concurrence.
- Performance Data: It states that performance has been "demonstrated via non-clinical bench type tests and analyses." However, it does not provide the results, acceptance criteria for these tests, or any details about a clinical study involving human patients or expert evaluations.
- FDA Clearance: The letter from the FDA confirms that based on the substantial equivalence argument, the device can be marketed.
Therefore, an answer based on your request and the provided text is not possible, as the necessary information for a detailed description of acceptance criteria, a supporting study, and related metrics (sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth) is absent.
The document is a regulatory submission for a medical device that establishes substantial equivalence to a predicate device, and thus, detailed performance metrics and studies are often not required in the same way they would be for a novel device or a device making new performance claims.
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KA60302
Page 1 of 3
APR 1 1 2006
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Appendix B
510 (k) Summary
| 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 | April 3, 2006. |
| Device TradeName | InScope™ Precision Balloon Dilator - Wire Guided |
| 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. |
| Product | The subject InScope Precision Balloon Dilator - Wire Guided described in |
Product this submission is virtually identical to its predicate device(s), which already Description have received 510(k) concurrence.
00058
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| Intended Use | ||
|---|---|---|
| The InScope Precision Balloon Dilator - Wire Guided - with pre-loaded0.035" guide wire - Is a sterile, single use, disposable dilator used in thealimentary tract (esophagus, pylorus and colon). In the sterile productpackaging also a stopcock is provided to maintain pressure or vacuum by aninflation device.The balloon specific pressure / diameter relationship is represented on thelabeling of each product. | ||
| Compared to the previously cleared predicate device - InScope PrecisionBalloon Dilator - Fixed Wire, the subject InScope Precision Balloon Dilator -Wire Guided in this submission now resembles the Boston Scientific's CREWireguided Balloon Dilator, which already received FDA 510(k)concurrence. | ||
| The InScope Precision Balloon Dilator is intended for use in adult andadolescent populations to endoscopically dilate strictures of the alimentarytract (i.e. esophagus, pylorus and colon). | ||
| 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 performance of the InScope Precision Balloon Dilator - Wire Guided hasbeen demonstrated via non-clinical bench type tests and analyses. The resultsfrom these tests are documented in detail in Section 6 -Performance Testingof this submission. The materials used in the subject device are found to bebiocompatible. |
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Substantial Equivalence Statement
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 patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA stated: "A determination of substantial 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 resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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APR 1 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Harm Hovinga Senior Regulatory Affairs Associate Cordis Europa N.V. Oosteinde 8 NL-9301 LJ Roden THE NETHERLANDS
Re: K060302
Trade/Device Name: InScope™ Precision Balloon Dilator- Wire Guided Regulation Number: 21 CFR §876.5365 Regulation Name: Esophageal dilator Regulatory Class: II Product Code: KNQ Dated: February 3, 2006 Received: February 6, 2006
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 (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 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) I ms letter will and in your finding of substantial equivalence of your device to a legally premation notification - rives 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 11 you dobt 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 Anot, production other general information on your responsibilities under the Act from the 601:37). I od may ookin surers, 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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Page 1 of 1 Effective Date: 11/15/00
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Intended Use Statement Appendix A:
Page 1 of 1
K060302 510(k) Number (if known):
Device Name:
InScope™ Precision Balloon Dilator - Wire Guided
Indications for Use Statement
The InScope Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the alimentary tract (i.e. esophagus, pylorus and colon).
(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)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K060302 |
|---|---|
| --------------- | --------- |
§ 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.