(174 days)
Not Found
No
The description focuses on mechanical components (plunger, manometer, tube) and pressure control, with no mention of AI/ML terms or functionalities.
No.
The device's intended use is to inflate and deflate balloons on dilatation catheters, which are therapeutic, but the inflation device itself does not directly treat a disease or condition. It is an accessory to a therapeutic device.
No
The device description states its use is to "create and monitor the pressure in the balloon and to deflate the balloon," which is an instrumental function, not a diagnostic one. It assists in a procedure rather than diagnosing a condition.
No
The device description explicitly lists physical components like a palm grip, plunger, manometer, and connecting tube, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to inflate, monitor pressure in, and deflate balloons on balloon dilatation catheters. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details mechanical components for controlling pressure and a manometer for measurement. These are consistent with a device used in a medical procedure, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Predicate Devices: The predicate devices listed are also inflation devices used with catheters, further supporting its non-IVD classification.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
Product codes
78 KOE, 78 MAV
Device Description
The Athor Modiour & Locking palm grip that control that control the plunger, a manometer to measure pressure and a connecting tube.
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
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.
Key Metrics
Not Found
Predicate Device(s)
K972964, K962611, K953522, K955869
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Road | |
| Arab, AL 35016 | |
| Contact: | Mr. Dan Clark, |
| Atrion Medical Products, Inc. | |
| 1426 Curt Francis Road | |
| Arab, AL 35016 | |
| Telephone: (256) 586-1580, ext. 220 | |
| Fax: (256) 586-8529 | |
| Email: 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.
1
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.
2
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
3
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) | ✓ |
|---|---|
| ------------------------------------------ | -------------- |
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