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.

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 When the device is unlocked the threaded plunger may be advanced or withdrawn.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).

AI/ML Overview

This document describes the 510(k) summary for the SterilMed Reprocessed Balloon Inflation Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and performance against those criteria in the way envisioned by the prompt.

Therefore, many of the requested sections (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in the given text because the 510(k) submission for a reprocessed device typically relies on demonstrating that the reprocessed device performs comparably to the original and its predicate, rather than conducting new clinical trials or extensive performance studies with ground truth.

Here's the information that can be extracted and synthesized from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance (General)	Representative samples underwent bench testing to demonstrate appropriate functional performance.
Cleaning Validation	Process validation testing was performed to validate the cleaning procedures.
Sterilization Validation	Process validation testing was performed to validate the sterilization procedures.
Packaging Validation	Process validation testing was performed to validate the device's packaging.
Visual Inspection	The manufacturing process includes visual testing of all products produced.
Functional Testing (Manufacturing)	The manufacturing process includes functional testing of all products produced.
Substantial Equivalence (Overall)	The Reprocessed Balloon Inflation Device is substantially equivalent to the Encore 26 Inflation Device (K955869) based on similarities in functional design, materials, indications for use, and methods of construction.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not explicitly stated. The document mentions "representative samples" for bench testing and "all products produced" for manufacturing testing, but specific numbers are not provided.
Data Provenance: Not specified, but generally, bench testing data for 510(k) submissions are generated domestically by the submitter (SterilMed, Inc. is in Minneapolis, MN). The study is prospective in the sense that testing was conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided. This type of information is typically required for diagnostic devices where subjective interpretation or a definitive "ground truth" (e.g., disease presence/absence) needs independent verification. For a reprocessed mechanical device, ground truth is established through objective engineering tests and comparisons to specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / None (as per medical imaging/clinical trial context). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies. For a mechanical device, performance is typically objectively measured against pre-defined specifications, and any deviation would be assessed by engineering personnel.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant to diagnostic AI-powered devices, not a reprocessed mechanical surgical tool like a balloon inflation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is purely mechanical and does not involve any algorithms or AI for standalone performance evaluation. Its function is to create and monitor pressure and deflate a balloon, which is a direct physical action.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Engineering Specifications and Predicate Device Performance: The "ground truth" for this device is effectively its ability to meet the original design specifications of a new device and to perform equivalently to the predicate device (Encore 26 Inflation Device, K955869). This is assessed through objective criteria in bench testing (e.g., pressure generation, pressure monitoring accuracy, locking mechanism function, durability) and validation of reprocessing effectiveness (cleaning, sterility, packaging integrity).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is a mechanical device, not an AI/machine learning model.

9. How the ground truth for the training set was established

Not Applicable. There is no "training set" for this type of device.

Summary

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K053188

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ול בין או ביינונג

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510(K) SUMMARY

Submitter:	SterilMed, Inc.
	Contact Person:Dr. Bruce LesterSterilMed, Inc.11400 73rd Avenue NorthMinneapolis, MN 55369
Date Prepared:	November 14, 2005
Trade Name:	Reprocessed Balloon Inflation Device
Classification Name:	Injector and Device, Angiographic, BalloonInflation, Reprocessed
Classification Number:	Class II; 870 1650
Product Code:	NKU
Predicate Device(s):	The SterilMed Reprocessed Balloon Inflation Device issubstantially equivalent to the Encore 26 InflationDevice manufactured by Boston Scientific (K955869cleared March 22, 1996).
Device Description:	The Reprocessed Balloon Inflation Device consists of athreaded plunger, locking mechanism, pressure gauge,Device and connecting tube. A finger latch controls thelocking mechanism on the device. When the device isunlocked the threaded plunger may be advanced orwithdrawn. Locking of the device allows for generationand monitoring of pressure in atmospheres (atm) andpounds per square inch (psi).

SterilMed Inc 510(k) Premarket Notification Reprocessed Balloon Inflation Device

11/14/2005

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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.

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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

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INDICATIONS FOR USE

K053188

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

Regulation Number and Section

§ 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.