(102 days)
The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
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 passage of a guidewire.
The provided text describes a medical device, the CRE™ Pulmonary Balloon Dilatation Catheter, and its 510(k) submission for clearance. However, the document does not contain specific acceptance criteria, detailed information about a study proving the device meets those criteria, or the other requested details such as sample sizes, expert qualifications, or ground truth establishment.
The document states:
- "In-Vitro Testing has been performed and all full devices met the required specifications for the completed tests."
- "A summary of the test results has been provided for Kink Resistance, Scope Insertion, Scope Removal, Inflation Time and Deflation Time."
This indicates that performance testing was conducted, and the device met its internal specifications, but these specifications themselves are not presented as "acceptance criteria" in the format requested. The document is a 510(k) summary, which typically provides an overview rather than granular study details.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The specific criteria values and detailed performance metrics are not included.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is in-vitro testing, not expert-adjudicated clinical data.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not mentioned and unlikely for this type of device and submission.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: For in-vitro testing, the "ground truth" would be the predetermined engineering specifications or physical measurements, which are not detailed here. No clinical ground truth (pathology, outcomes) is reported.
- Sample size for the training set: Not applicable as this is a physical device, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable for the same reason.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (K023337) based on the modification of catheter shaft working length and adherence to manufacturing specifications via in-vitro testing. It does not provide the detailed study information you requested for an AI/algorithm-based device or a clinical outcome study.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2017
Boston Scientific Corporation Jia Huang Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K170759
Trade/Device Name: CRE™ Pulmonary Balloon Dilatation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: KTI Dated: May 23, 2017 Received: May 24, 2017
Dear Jia Huang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170759
Device Name
CRE Pulmonary Balloon Dilatation Catheter
Indications for Use (Describe)
The CRE Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
Type of Use (Select one or both, as applicable)> Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
| Contact: | Jia Huang |
|---|---|
| Sr. Regulatory Affairs Specialist | |
| Email: | Jia.Huang@bsci.com |
| Telephone: | (508) 683-4360 |
| Fax: | (508) 683-5939 |
Date Prepared: March 9, 2017
2. Device
| Trade Name: | CRE™ Pulmonary Balloon Dilatation Catheter |
|---|---|
| Common Name: | Balloon Dilatation Catheter |
| Classification Name: | Bronchoscope (flexible and rigid) and accessories |
| Regulation Number: | 21 CFR 874.4680 |
| Product Code: | KTI |
| Classification: | Class II |
3. Predicate Device
| Trade Name: | CRE™ Pulmonary Balloon Dilatation Catheter |
|---|---|
| Common Name: | Balloon Dilatation Catheter |
| Manufacturer: | Boston Scientific Corporation |
| Clearance Number: | K023337 |
| Classification Name: | Bronchoscope (flexible and rigid) and accessories |
| Regulation Number: | 21 CFR 874.4680 |
| Product Code: | KTI |
| Classification: | Class II |
4. Reference Device
| Trade Name: | ElationTM Pulmonary Balloon Dilatation Cathete |
|---|---|
| Common Name: | Pulmonary Balloon Dilatation Catheter |
| Manufacturer: | Merit Medical Systems, Inc. |
| Clearance Number: | K161392 |
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Classification Name: Bronchoscope (flexible and rigid) and accessories Regulation Number: 21 CFR 874.4680 Product Code: KTI Classification: Class II
5. 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 passage of a guidewire.
6. Indications for Use
The CRE™ Pulmonary Balloon Dilatation Catheter is intended to be used endoscopically to dilate strictures of the airway tree.
7. Technologies Characteristics
The changes are modifying the design of the CRE™ Pulmonary Balloon Dilatation Catheter to be able to use the device through a flexible bronchoscope working channel by increasing the length of the catheter shaft. The proposed CRE™ Pulmonary Balloon Dilatation Catheter is identical to the predicate CRE™ Pulmonary Balloon Dilatation Catheter (K023337), with the exception of catheter shaft working length.
8. Performance Data
In-Vitro Testing has been performed and all full devices met the required specifications for the completed tests. A summary of the test results has been provided for Kink Resistance, Scope Insertion, Scope Removal, Inflation Time and Deflation Time.
9. Conclusion
Boston Scientific Corporation has demonstrated that the proposed CRE™ Pulmonary Balloon Dilatation Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed CRE™ Pulmonary Balloon Dilatation Catheter (K023337).
§ 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.