(42 days)
Not Found
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended to be used for dilating strictures of the airway tree, which is a therapeutic intervention aimed at treating medical conditions.
No
The device description states its purpose is to "dilate strictures of the airway tree," which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a physical catheter with an inflatable balloon and lumens, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate strictures of the airway tree" using a balloon catheter. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device used for mechanical dilation within the airway.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide diagnostic information. IVDs are typically used for testing and analysis of biological samples.
Therefore, the CRE™ Pulmonary Balloon Dilatation Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
Product codes (comma separated list FDA assigned to the subject device)
77 KTI
Device Description
The CRE™ Pulmonary Balloon Dilatation Catheter is used to access the airway tree via a bronchoscope for the purpose of dilating strictures. It consists of an inflatable balloon on a catheter shaft with lumens for inflation and guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway tree
Indicated Patient Age Range
Not Found
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)
Not Found
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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NOV 1 8 2002
SECTION 14 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(I)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket 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.
| Date: | October 4, 2002 | ||
|---|---|---|---|
| Common/Usual Names: | Balloon Dilatation Catheter | ||
| Trade/Proprietary Names: | CRETM Pulmonary Balloon Dilatation Catheter | ||
| Classification Name & | |||
| Device Classification: | Class II | ||
| Name | Number | 21CFR Ref. | |
| Bronchoscope & Acc. | 77 KTI | 874.4680 | |
| Device Panel/Branch: | Ear, Nose and Throat (ENT) | ||
| Owner/Operator: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Contact Person: | Paige Sweeney | ||
| Regulatory Affairs Specialist |
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Description of Devices
The CRE™ Pulmonary Balloon Dilatation Catheter is used to access the airway tree via a bronchoscope for the purpose of dilating strictures. It consists of an inflatable balloon on a catheter shaft with lumens for inflation and guidewire.
Indications for Use
The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
Descriptive and Technological Characteristics of Proposed and Predicate Devices
Boston Scientific Corporation believes that the CRE™ Pulmonary Balloon Dilatation Catheter is substantially equivalent to the currently marketed CRE™ Balloon Dilatation Catheter. The major components of these devices are the balloon, catheter shaft, and proximal hub. A thorough comparison of the descriptive characteristics between the proposed devices and the predicate devices show equivalence.
Conclusion
Boston Scientific Corporation has demonstrated that the CRE™ Pulmonary Balloon Dilatation Catheter is substantially equivalent to the currently marketed CRE™ Balloon Dilatation Catheter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Public Health Service
The page you requested could not be found. Every effort has been made to ensure the accuracy of the information on this website; however, errors and omissions are possible. We advise you to contact us directly if you have any questions or concerns.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2002
Boston Scientific, Corp. c/o Paige Sweeney Regulatory Affairs Specialist Microvasive Endoscopy One Boston Scientific Place Natick, MA 01760
Re: K023337
Trade/Device Name: CRE™ Pulmonary Balloon Dilation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dated: October 4, 2002 Received: October 7. 2002
Dear Ms. Sweeney:
We have reviewed vour 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 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 I·DA`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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Page 2 - Paige Sweeney
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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlv/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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SECTION 3 INDICATIONS FOR USE
K023337 510(k) Number: To Be Determined
Device Name: CRETM Pulmonary Balloon Dilatation Catheter -
The CRE™ Pulmonary Balloon Dilatation Catheter is intended Indication for Use: to be used endoscopically to dilate strictures of the airway tree.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _ Prescription Use _ OR (Per 21CFR 801.1091) (Optional Format 1-2-96)
Karen H. Bohrer
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
Ko 23337 510(k) Number _
510(k) Premarket Notification for CRE™ Pulmonary Balloon Dilatation Catheter Proprietary and Confidential Information of Boston Scientific Corporation
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