(36 days)
Not Found
Not Found
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The device is a mechanical balloon dilator.
Yes
The device is intended to treat a medical condition (dilating strictures of the esophagus) by directly acting on the body, which aligns with the definition of a therapeutic device.
No
The device is a dilator used for treatment, not diagnosis. It expands strictures rather than identifying or characterizing them.
No
The device description clearly outlines a physical, sterile, single-use, disposable esophageal dilator with a balloon, marking bands, and a stopcock. This is a hardware device, not software.
Based on the provided information, the InScope™ Precision Balloon Dilator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the esophagus." This is a therapeutic procedure performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical device used for mechanical dilation, not for analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of providing diagnostic results or information about a patient's health status based on laboratory analysis.
Therefore, the InScope™ Precision Balloon Dilator is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InScope™ Precision Balloon Dilator is intended for use in adult and adolescent populations to endoscopically dilate strictures of the esophagus.
Product codes (comma separated list FDA assigned to the subject device)
78 KNQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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 safety and effectiveness of the InScope Precision Balloon Dilator has been demonstrated via data collected from non-clinical bench type tests and analyses. The materials used in the subject device are found to be biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
.
Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a combination of alphanumeric characters and words. The first line reads 'K043605', which seems to be a code or identifier. The second line reads '1 of 3', which likely indicates a page number or a sequence within a set of documents.
Image /page/0/Picture/2 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underlining it. Below the line, the text "a Johnson-Johnson company" is written in a smaller, italicized font. The logo is simple and professional, reflecting the company's corporate identity.
Appendix B
| 510 (k) Summary of Safety and Effectiveness | |
|---|---|
| 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 | December 23, 2004 |
| Device Trade | |
| Name | InScope Precision balloon Dilator |
| 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. |
1
ZCU36CS
p2 of 3
Image /page/1/Picture/1 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underlining it. Below the line, in a smaller, more cursive font, it says "a Johnson & Johnson company."
| Product
Description | 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. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The InScope™ Precision Balloon Dilator is intended for use in adult and
adolescent populations to endoscopically dilate strictures of the esophagus. |
| 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 safety and effectiveness of the InScope Precision Balloon Dilator has
been demonstrated via data collected from non-clinical bench type tests and
analyses. The materials used in the subject device are found to be
biocompatible. |
Substantial Equivalence Statement
2
2CL4365
p3cf3
Image /page/2/Picture/1 description: The image shows the word "Cordis" in a bold, sans-serif font. The word is underlined with a thick black line. The text is black against a white background, creating a high contrast.
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).
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is in black and white.
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.
4
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
5
Cordis Franchise Form - CFF 20-014 Rev.01 Intended Use Statement
Page 1 of 1 Effective Date: 11/15/00
Image /page/5/Picture/2 description: The image shows the logo for Cordis, a Johnson & Johnson company. The word "Cordis" is written in a bold, sans-serif font, with a thick line underneath it. Below the line, the words "a Johnson & Johnson company" are written in a smaller, cursive font. The logo is simple and professional, and it clearly identifies the company.
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 |