(147 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical balloon catheter and its performance and biocompatibility testing, with no mention of AI or ML.
Yes.
The device is used for percutaneous transluminal angioplasty, which is a therapeutic intervention to treat narrowed or obstructed vessels.
No
The device is a balloon dilatation catheter used for therapeutic angioplasty, not for diagnosis. Its purpose is to treat narrowed or obstructed vessels, not to identify or characterize medical conditions.
No
The device description clearly states it is a "Balloon Dilatation catheter," which is a physical medical device, not software. The performance studies also focus on physical characteristics like balloon burst testing and biocompatibility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the Blue Max 20 Balloon Dilatation Catheter is used for Percutaneous Transluminal Angioplasty. This is a procedure performed inside the body to widen narrowed blood vessels. It's a therapeutic intervention, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use is to treat obstructive lesions in arteries and fistulae, which is a direct treatment of a medical condition, not a diagnostic assessment.
The information provided describes a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Blue Max 20 Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
74 LIT
Device Description
The proposed Blue Max™ -20 Balloon Dilatation catheter is an over-the-wire catheter with two lumens indicated for percutaneous transluminal angioplasty of narrowed or obstructed vessels in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Iliac, Femoral and Renal Arteries; native or synthetic arteriovenous dialysis fistulae.
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
The following in vitro frunctional tests were performed on the Blue Max™ -20 Balloon Dilatation Catheter: - Balloon Burst Testing . Multiple Inflation Testing . Inflation/Deflation Time Testing . Balloon Compliance Testing - Balloon Proximal Bond Testing . Sheath Withdrawal Testing
The following biocompatibility tests were performed: - Cytotoxicity . Irritation . Hemolysis . Acute Systemic Toxicity . Mutagenicity . Sensitization . Implantation . Pyrogenicity . Subchronic Toxicity .
Key Metrics
Not Found
Predicate Device(s)
BSC -- Blue Max Balloon Dilatation Catheter, BSC -- Ultra-thin Diamond Balloon Dilatation Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Medi-tech Blue Max™ -20 Balloon Dilatation Catheter
June 24, 1997
ATTACHMENT H
NOV 1 9 1997 SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification either an "... 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 choose to submit a summary of information respecting safety and effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph (A) respecting a device shall contain detailed information regarding data concerning adverse health effects ... "
The summary regarding the adverse health effects of the proposed Blue Max™ -20 Balloon Dilatation Catheter is as follows:
| Trade Name: | Blue Max™ -20 Balloon Dilatation Catheter |
|---|---|
| Manufacturer: | Boston Scientific Corporation |
| One Boston Scientific Place | |
| Natick, MA 01760 | |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | According to Section 13 of the Federal Food, Drug and Cosmetic Act, the |
| device classification is Class II, Performance Standards. |
Predicate Devices:
The following devices are referenced in this premarket notification as predicate devices for the Blue Max™ -20 Balloon Dilatation Catheter:
BSC -- Blue Max Balloon Dilatation Catheter BSC -- Ultra-thin Diamond Balloon Dilatation Catheter
All of the devices mentioned above have been determined substantially equivalent by FDA.
Device Description:
The proposed Blue Max™ -20 Balloon Dilatation catheter is an over-the-wire catheter with two lumens indicated for percutaneous transluminal angioplasty of narrowed or obstructed vessels in the peripheral vasculature and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Safety and Performance:
The following in vitro frunctional tests were performed on the Blue Max™ -20 Balloon Dilatation Catheter:
- Balloon Burst Testing
- . Multiple Inflation Testing
- . Inflation/Deflation Time Testing
- . Balloon Compliance Testing
- Balloon Proximal Bond Testing
- . Sheath Withdrawal Testing
1
Medi-tech Blue Max™ -20 Balloon Dilatation Catheter
The following biocompatibility tests were performed:
- Cytotoxicity .
- Irritation .
- Hemolysis .
- Acute Systemic Toxicity .
- Mutagenicity .
- Sensitization .
- Implantation .
- Pyrogenicity .
- Subchronic Toxicity .
Conclusion:
Based on the Indications for Use, technological characteristics and safety and performance testing, the Blue Max™ -20 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Career States
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HU. AN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 19 1997
Ms. Mary P. LeGraw Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537
Re: K972357 Blue Max-20™ Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: 74 LIT Dated: November 5, 1997 Received: November 6, 1997
Dear Ms. LeGraw:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 ,895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Mary P. LeGraw
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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New Application
510(k) Number (if known):
Blue Max 20 Balloon Dilatation Catheter Device Name:
Indications For Use:
Blue Max 20 Balloon Dilatation Catheters are recommended for Percutaneous Transluminal Angioplasty of the Iliac, Femoral and Renal Arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tura A. Re
(Division Sign-O Division of Cardiova and Neurological De 510(k) Numbe
Prescription Use
(Per 21 CFR 201.109)
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Over-The-Counter Use_
(Optional Format 1-2-96)
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