The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

Device Description

The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Atrion Medical QL® Inflation Device". It is a submission for a medical device, and as such, the concept of "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood in the context of clinical trials for diagnostic algorithms or AI models does not directly apply here.

Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices, which is the primary regulatory pathway for devices like this. Substantial equivalence means that the new device is as safe and effective as a legally marketed device that is not subject to PMA (Premarket Approval).

Here's an analysis based on the provided text, addressing the points you requested where applicable, and highlighting why some points are not relevant to this type of device and submission:

Analysis of Acceptance Criteria and Device Performance for Atrion Medical QL® Inflation Device (K032840)

1. Table of Acceptance Criteria and Reported Device Performance:

For a device like the Atrion Medical QL® Inflation Device, the "acceptance criteria" are primarily based on demonstrating that it performs equivalently to predicate devices in its fundamental functions and does not raise new questions of safety or effectiveness. The document states:

Criterion/Parameter (Implicit "Acceptance Criteria")	Reported Device Performance / Justification
Intended Use Equivalence	"The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon." This is identical to the stated function of predicate devices.
Operating Pressure Range	"The Atrion Medical QL® Inflation Device has an operating pressure range of vacuum to [missing number for max pressure, but implies a range similar to predicates]." "While the predicate devices have a [missing number] alln, depending on the manometer [missing number] ending on the predicate." Implication: The operating pressure range is comparable and suitable for its intended use with balloon dilatation catheters.
Material Biocompatibility	"The materials of the device which contact the solution in use have been tested using [unspecified methods, but states that] these studies indicate that the product is safe for its intended use."
Absence of New Safety/Effectiveness Concerns	"There are no other characteristics that distinguish the two devices [new vs. predicate], and no differences that should pose a risk to patient safety."

2. Sample Size Used for the Test Set and Data Provenance:

This information is not applicable to this type of 510(k) submission. The "test set" and "data provenance" as described in the context of AI/diagnostic algorithm validation (e.g., country of origin, retrospective/prospective) are not relevant here. This submission relies on engineering testing and comparison to predicate device specifications, rather than clinical data sets in that sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

This information is not applicable. The "ground truth" for a device like an inflation device is based on objective engineering specifications (pressure, material safety, leak integrity, etc.) and its functional equivalence to predicate devices, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations, typically in diagnostic studies. This is not how the performance of an inflation device is evaluated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This information is not applicable. MRMC studies are used to assess the impact of a diagnostic tool on human reader performance. The Atrion Medical QL® Inflation Device is a surgical accessory, not a diagnostic tool requiring such a study.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's safety and effectiveness determination is primarily based on:

Engineering Specifications and Performance Testing: Demonstrating the device meets its functional requirements (e.g., pressure range, leak-free operation, material integrity).
Predicate Device Equivalence: Showing that its design, materials, and intended use are substantially equivalent to previously cleared devices.
Biocompatibility Testing: Ensuring materials in contact with body fluids are safe.

8. The sample size for the training set:

This information is not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The design and testing are based on engineering principles and regulatory standards.

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

This information is not applicable for the same reasons as point 8.

Summary

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K032-840

12. SUMMARY OF SAFETY AND EFFECTIVENESS

Date of Preparation:	September 9, 2003
Device Name:	Atrion Medical QL® Inflation Device
Classification Name:	Balloon Inflation/Deflation Device
Manufacturer:	Atrion Medical Products, Inc.PO Box 564, 1426 Curt Francis RoadArab, AL 35016
Contact:	Mr. Dan Clark,Atrion Medical Products, Inc.1426 Curt Francis RoadArab, AL 35016Telephone: (256) 586-1580, ext. 220Fax: (256) 586-8529Email: dclark@atrionmedical.com

Predicates:

Atrion Medical Products Balloon Catheter Inflation Device, K972964. Athon Mediour Productional (Bard Eagle) Urological Balloon Catheter Inflation Device, K962611 Ryder International (USCI Ideal) Balloon Catheter Inflation Device, K953522 Scimed Encore 26 and Encore 30 Inflation Devices, K955869

Device Description:

Device Description: The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.

Intended Use:

The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

Technological Characteristics:

The Atrion Medical QL® Inflation Device has an operating pressure range of vacuum to The Athor Medical QL® Innation Dother Hached, while the predicate devices have a 40 alln, depending on the manomote ending on the predicate. There are no other range of valuant to it characteristics that distinguish the two devices, and no differences that should pose a risk to patient safety.

Testing:

The materials of the device which contact the solution in use have been tested using The materials of the do not these studies indicate that the product is safe for its intended use.

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Image /page/1/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 an emblem featuring a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2004

Mr. Dan Clark Vice President Regulatory and Quality Atrion Medical Products, Inc. P.O. Box 564 1426 Curt Francis Road ARAB AL 35016

Re: K032840

Trade/Device Name: Atrion Medical QL® Inflation Device Regulation Number: 21 CFR §876.5520 Regulation Name: Urethral dilator Product Code: 78 KOE Regulation Number: 21 CFR §870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: II-Product Code: 78 MAV Dated: January 14, 2004 Received: January 16, 2004

Dear Mr. Clark:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to the enactment date of the Medical Device Amendments, or to conninered pror to they 20, 2017 11:57 accordance with the provisions of the Federal Food, Drug, de noos that have been that do not require approval of a premarket approval application (PMA). and Cosmette Act (110.) that Concerner subject to the general controls provisions of the Act. The r on may, therefore, maines of the Act include requirements for annual registration, listing of general controll provisions practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Spccial 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i that FDA has made a determination that your device complies with other requirements of the Act that I Dry has made a astd regulations administered by other Federal agencies. You must or any I ederal statutes and requirements, including, but not limited to: registration and listing Comply with an the Hot in (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 087), acomisg (2S) regulation (21 CFR Part 820); and if applicable, the electronic form in the quant of a provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k)
1972) 1 This letter will allow you to begin marketing your intist equivalence of your device to a legally premarket notification. The FDA inding of succements of the succe 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 of If you desire specific advice for your device on on the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotive and as a sected to regulation entitled, "Masbranding, of ther agencral Office of Compliance at (301) 594-4057. This, post 807.97) you may obtain. Other general by reference to premarket nonication (21CH F are over (1) jocd from the Division of Small
information on your responsibilities under the Act may be obtained from the (800) 6 information on your responsionalizes under the Assistance at its toll-free mumber (80) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free manag Manufacturers, International and Collisation Assistences in the Marian and Smamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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13. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Ko32$46

Device Name: Atrion Medical QL® Inflation Device

Indications For Use:

The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor
and money of the first and the the ballean The immation Device is foot and to deflate the balloon.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF

NET - CONTINE BELOW - NEEDED) NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
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OR Over-The- Counter Use
(Optional Format 1-2-96)

(Division Sig	Nancy Brogdon
Division of Re ctive, Abdominal,and Radiological Devices
510(k) Number	K032840

000059

Regulation Number and Section

§ 876.5520 Urethral dilator.

(a)
Identification. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.(b)
Classification. (1) Class II (special controls). Except when it is a mechanical urethral dilator, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.