(189 days)
Not Found
Not Found
No
The summary describes a physical medical device (a balloon catheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, a balloon dilatation catheter, is used for percutaneous transluminal angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a therapeutic intervention.
No
This device, a balloon dilatation catheter, is used for percutaneous transluminal angioplasty (PTA), which is a therapeutic procedure to open narrowed or obstructed blood vessels. It is not described as being used to diagnose a condition, but rather to treat one.
No
The device description clearly identifies it as a physical catheter with a balloon, which is a hardware component. The performance studies also focus on physical properties and biocompatibility of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The description clearly states that the SC 35 Balloon Dilatation Catheter is used for "percutaneous transluminal angioplasty" and "treatment of obstructive lesions" within blood vessels and fistulae inside the body. This is an interventional procedure performed directly on the patient.
- Lack of IVD Characteristics: The document does not mention any testing of specimens, analysis of biological samples, or any of the typical components or processes associated with IVD devices (reagents, analyzers, etc.).
The SC 35 Balloon Dilatation Catheter is a therapeutic medical device used for a surgical/interventional procedure.
N/A
Intended Use / Indications for Use
The SC 35 Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter indicated for percutaneous transluminal angioplasty of the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, renal arteries and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The proposed device is designed to be placed over guidewires which have outer diameters of .035" or smaller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infrapopliteal, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following in vitro functional tests were performed on the SC 35 Balloon Dilatation Catheter:
- Balloon Burst Testing
- . Multiple Inflation Testing
- . Inflation/Deflation Time Testing
- Balloon Compliance Testing .
- . Balloon Proximal Bond Testing
- . Sheath Withdrawal Testing
- Wingfolded Balloon Profile Testing .
- Coating Coefficient of Friction Testing ●
- . Particulate Analysis Testing
- . Solvent Residual Testing
The following biocompatibility tests were performed:
- Cytotoxicity .
- . Hemolysis
- . Acute Intracutaneous Reactivity
- . Acute Systemic Toxicity
- . Sensitization
- . Pyrogenicity
Based on the Indication for Use, technological characteristics and safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.
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
§ 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
SC 35 Balloon Dilatation Catheter
September 23, 1999
ATTACHMENT H
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 chooses 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 SC 35 Balloon Dilatation Catheter is as follows: र्
| Trade Name: | SC 35 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 SC 35 Balloon Dilatation Catheter: |
Boston Scientific Corporation - Ultra-thin DiamondTM Balloon Dilatation
Catheter
Boston Scientific Corporation - Courier STTM Balloon Dilatation Catheter
All of the devices mentioned above have been determined substantially
equivalent by FDA. |
| Device Description: | The proposed SC 35 Balloon Dilatation catheter is an over-the-wire catheter
indicated for percutaneous transluminal angioplasty of the iliac, femoral,
ilio-femoral, popliteal, infrapopliteal, renal arteries and for treatment of
obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The
proposed device is designed to be placed over guidewires which have
outer diameters of .035" or smaller. |
1
SC 35 Balloon Dilatation Catheter
September 23, 1999
Indications for Use:
The SC 35 Balloon Dilatation Catheter is indicated for PTA of the iliac, femoral, ilio-femoral, popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Safety and Performance:
The following in vitro functional tests were performed on the SC 35 Balloon Dilatation Catheter:
- Balloon Burst Testing
- . Multiple Inflation Testing
- . Inflation/Deflation Time Testing
- Balloon Compliance Testing .
- . Balloon Proximal Bond Testing
- . Sheath Withdrawal Testing
- Wingfolded Balloon Profile Testing .
- Coating Coefficient of Friction Testing ●
- . Particulate Analysis Testing
- . Solvent Residual Testing
The following biocompatibility tests were performed:
- Cytotoxicity .
- . Hemolysis
- . Acute Intracutaneous Reactivity
- . Acute Systemic Toxicity
- . Sensitization
- . Pyrogenicity
Conclusion:
Based on the Indication for Use, technological characteristics and safety and performance testing, the SC 35 Balloon Dilatation Catheter has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
APR 1 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terry A. McGovern Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
K993305 Re: Semi Compliant (SC) 35 Balloon Dilatation Catheter Regulatory Class: II (two) Product Code: LIT Dated: January 12, 2000 Received: January 18, 2000
Dear Ms. McGovern:
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 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). You may, therefore, market the device, subject to the general controls The general controls provisions of the Act provisions of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 requlation may result in requlatory 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. Terry A. McGovern
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 regulation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Chitophem. Ahtor
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
New Application
Device Name:
Semi-Compliant 35 Balloon Dilatation Catheter
The Semi-Compliant 35 Balloon Dilitation Indications for Use: Catheter is indicated for percutaneous transluminal angioplasty of the iliac, femoral, illio-femoral, popliteal, 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 OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chitophth for Dillard
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K993305
OR
Prescription Use / Use (Per 21 CRF 801.109)
Over-The-Counter
(Optional Format 1-2-96)