(64 days)
Not Found
Not Found
No
The summary describes a mechanical balloon dilator and explicitly states that AI/ML is "Not Found".
Yes
The device is used to dilate strictures in the alimentary tract, which is a therapeutic intervention.
No
The device is described as a dilator used to treat strictures in the alimentary tract, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly indicates it is a physical balloon dilator with a guide wire, stopcock, and packaging, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "endoscopically dilate strictures of the alimentary tract". This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a balloon dilator used for a physical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples. This device is used in vivo (in the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
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).
Product codes
KNQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract (esophagus, pylorus and colon)
Indicated Patient Age Range
adult and adolescent populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the InScope Precision Balloon Dilator - Wire Guided has been demonstrated via non-clinical bench type tests and analyses. The results from these tests are documented in detail in Section 6 -Performance Testing of this submission. The materials used in the subject device are found to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
KA60302
Page 1 of 3
APR 1 1 2006
:
Appendix B
510 (k) Summary
| Submitter's
name and
address | Cordis Europa, NV
Oosteinde 8
NL-9301 LJ Roden
The Netherlands |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person | Harm Hovinga
Senior Regulatory Affairs Associate
Tel: +31 - (5050) 22479
Fax: +31 - (5050) 22456
E-mail: hhovinga@crdnl.jnj.com |
| Date prepared | April 3, 2006. |
| Device Trade
Name | InScope™ Precision Balloon Dilator - Wire Guided |
| Common
Name | Esophageal dilator |
| Classification
Name | KNQ 21 CFR 876.5365 Esophageal dilator |
| Device
Classification | Class II. |
| Performance
standards | FDA has not (yet) established specific performance standards for this device
under 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
:
1
| Intended Use | ||
|---|---|---|
| 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. | ||
| 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 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). | ||
| Technological | ||
| comparison | Comparisons of the subject and the predicate device(s) show that | |
| technological characteristics, such as materials, mode of operation, | ||
| performance properties, biocompatibility, sterilization and packaging are | ||
| considered substantially equivalent to the currently marketed predicate | ||
| devices. | ||
| Performance | ||
| Data | The performance of the InScope Precision Balloon Dilator - Wire Guided has | |
| been demonstrated via non-clinical bench type tests and analyses. The results | ||
| from these tests are documented in detail in Section 6 -Performance Testing | ||
| of this submission. The materials used in the subject device are found to be | ||
| biocompatible. |
.
.
2
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).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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.
4
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
5
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 |
|---|---|
| --------------- | --------- |