(170 days)
Not Found
No
The description focuses on mechanical components and pressure monitoring, with no mention of AI/ML terms or functionalities.
No
The device is used in conjunction with a balloon dilatation catheter, which is the likely therapeutic device. The text describes the inflation device's function as creating, monitoring, and deflating pressure in the balloon of the catheter, making it a tool to facilitate the therapeutic action of the catheter itself, rather than a therapeutic device in its own right.
No
The device is described as an inflation device used to create, monitor, and deflate pressure in a balloon dilatation catheter. Its function is to assist in a procedure, not to diagnose a condition or disease.
No
The device description explicitly lists physical components such as a threaded plunger, locking mechanism, pressure gauge, and connecting tube, 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 clearly states that the device is used with balloon dilatation catheters to create, monitor, and deflate pressure in the balloon. This is a mechanical function performed in vivo (within the body) during a medical procedure.
- Device Description: The description details mechanical components (plunger, locking mechanism, pressure gauge, connecting tube) and their function in manipulating pressure. There is no mention of analyzing biological samples or performing tests in vitro (outside the body).
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on in vitro analysis.
The device is a tool used during a medical procedure to control the inflation and deflation of a balloon catheter, which is a therapeutic or diagnostic tool used within the body. This falls under the category of a medical device used for treatment or diagnosis in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.
Product codes
NKU
Device Description
The Reprocessed Balloon Inflation Device consists of a threaded plunger, locking mechanism, pressure gauge, Device and connecting tube. A finger latch controls the locking mechanism on the device. When the device is unlocked the threaded plunger may be advanced or withdrawn. Locking of the device allows for generation and monitoring of pressure in atmospheres (atm) and pounds per square inch (psi).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Representative samples of reprocessed Balloon Inflation Devices underwent bench testing to demonstrate appropriate functional performance. Process validation testing was performed to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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510(K) SUMMARY
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | |
| Dr. Bruce Lester | |
| SterilMed, Inc. | |
| 11400 73rd Avenue North | |
| Minneapolis, MN 55369 | |
| Date Prepared: | November 14, 2005 |
| Trade Name: | Reprocessed Balloon Inflation Device |
| Classification Name: | Injector and Device, Angiographic, Balloon |
| Inflation, Reprocessed | |
| Classification Number: | Class II; 870 1650 |
| Product Code: | NKU |
| Predicate Device(s): | The SterilMed Reprocessed Balloon Inflation Device is |
| substantially equivalent to the Encore 26 Inflation | |
| Device manufactured by Boston Scientific (K955869 | |
| cleared March 22, 1996). | |
| Device Description: | The Reprocessed Balloon Inflation Device consists of a |
| threaded plunger, locking mechanism, pressure gauge, | |
| Device and connecting tube. A finger latch controls the | |
| locking mechanism on the device. When the device is | |
| unlocked the threaded plunger may be advanced or | |
| withdrawn. Locking of the device allows for generation | |
| and monitoring of pressure in atmospheres (atm) and | |
| pounds per square inch (psi). |
.
SterilMed Inc 510(k) Premarket Notification Reprocessed Balloon Inflation Device
:
11/14/2005
.
1
| Intended Use: | The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon. |
|---|---|
| Functional and Safety Testing: | Representative samples of reprocessed Balloon Inflation Devices underwent bench testing to demonstrate appropriate functional performance. Process validation testing was performed to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced. |
| Conclusion: | The Reprocessed Balloon Inflation Device is substantially equivalent to the Encore 26 Inflation Device manufactured by Boston Scientific (K955869 cleared March 22, 1996). This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three wavy lines or stripes, possibly representing a flag or banner.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2006
SterilMed, Inc c/o Mr. Dennis Toussaint Regulatory Affairs Director 11400 73rd Avenue North, Suite 100 Maple Grove, Minnesota 55369
Re: K053188
Trade/Device Name: Reprocessed Balloon Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: NKU Dated: April 25, 2006 Received: April 26, 2006
Dear Mr. Toussaint:
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, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA). 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misburanding 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 FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements not 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.
3
Page 2 - Mr. Dennis Toussaint
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/industry/support/index.html .
Sincerely yours,
Duna R. lochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Page 3 – Mr. Dennis Toussaint
List of Model(s): Boston Scientific Encore 26 Inflation Device
11 - 12 - 12 - 12 - 12 ..
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
and the comments of the comments of
:
and the comments of the comments of
5
INDICATIONS FOR USE
Device Name: Reprocessed Balloon Inflation Device
Indications for Use:
The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE ( IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R-va dines
Jivision Sign-Off) vision of Cardiovascular Devis
510(k) Number_Kos 3188