(75 days)
Not Found
No
The 510(k) summary describes a mechanical device (a balloon catheter) used as an accessory to another mechanical device. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The modifications are purely physical (catheter tip, balloon material).
Yes
The device is stated to be an "accessory" to a "Percutaneous Thrombolytic Device" and is intended to be used on patients with "hemodialysis graft malfunction, due to thrombosis" to "pull the arterial plug" for removal, which directly addresses a medical condition.
No
The device is described as an accessory to a thrombolytic device, intended to physically remove an "arterial plug" for subsequent maceration and removal. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly describes a physical catheter with a balloon, materials, construction, and manufacturing processes. It also details performance tests related to the physical components (tensile test, integrity tests). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to physically manipulate and remove a thrombus (blood clot) from a hemodialysis graft. This is a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a catheter with a balloon, designed for mechanical action within the blood vessel. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: The text 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 samples
- Providing information for diagnosis, monitoring, or screening
The device is an accessory to another medical device used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
This device is intended to be used only as (and only indicated as) an accessory to our Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used on patients who are experiencing hemodialysis graft malfunction, due to thrombosis. This device is to be used to pull the arterial plug, located at the arterial anastamosis, into the arterial limb of the graft so it can be macerated by using the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device and removed.
The Arrow Balloon Embolectomy Catheter is indicated for use as an accessory to the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used to remove the arterial plug from the arterial anastamosis of a thrombosed hemodialysis access graft.
Product codes (comma separated list FDA assigned to the subject device)
DXE
Device Description
The proposed device is identical to the legally marketed Arrow Single-Lumen 5F x 60 cm Balloon Wedge Pressure Catheter with regards to materials, construction, and manufacturing processes. Minor modifications have been made to the catheter tip and the latex balloon to enhance performance.
The functions and indications for use of the new device are substantially equivalent to those of the Baxter Fogarty® Thru-Lumen Embolectomy Catheter, K892410.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial anastamosis
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 performance tests included in the submission include:
- Latex balloon tensile test 1.
-
- Biocompatibility tests
-
- Catheter Integrity tests
No clinical testing was performed.
The results of the laboratory tests demonstrated that the device is safe, and as effective, if not more effective, as the legally marketed predicate devices.
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.
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
AUG 3 | 1998
Arrow International, Inc.
KG82141
ARROW Balloon Embolectomy Ca Page 6
SECTION 2. 510(k) SUMMARY
510(k) Summary
Submitter:
Arrow Interntional, Inc. 2400 Bernville Road Reading, PA 19605
| Contact Person: | Thomas D. Nickel |
|---|---|
| Vice President, Regulatory Affairs and Quality Assurance | |
| (610) 478-3137 |
Date summary prepared: June 15, 1998
Device:
Arrow Balloon Embolectomy Catheter Trade Name:
Embolectomy Catheter Common Name:
Classification Catheter embolectomy, 74DXE, and 21 CFR 870.5150, Name: Embolectomy catheter
Legally marketed device to which the device is substantially equivalent:
-
- Arrow 5 Fr Balloon Wedge Pressure Catheter, Al-07123, a pre-amendment device. (Arrow Balloon Wedge Pressure Catheter)
-
- Baxter 4 Fr Fogarty® Thru-Lumen Embolectomy Catheter, 12TLW804F, Premarket notification number: K892410. (Baxter Catheter)
Description of device:
The proposed device is identical to the legally marketed Arrow Single-Lumen 5F x 60 cm Balloon Wedge Pressure Catheter with regards to materials, construction, and manufacturing processes. Minor modifications have been made to the catheter tip and the latex balloon to enhance performance.
The functions and indications for use of the new device are substantially equivalent to those of the Baxter Fogarty® Thru-Lumen Embolectomy Catheter, K892410.
1
Intended use of the device:
This device is intended to be used only as (and only indicated as) an accessory to our Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used on patients who are experiencing hemodialysis graft malfunction, due to thrombosis. This device is to be used to pull the arterial plug, located at the arterial anastamosis, into the arterial limb of the graft so it can be macerated by using the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device and removed.
Technological characteristics:
The device has the same technological characteristics as the predicates, with the only difference being the longer catheter tip and heavier wall latex balloon to enhance performance.
The performance tests included in the submission include:
- Latex balloon tensile test 1.
-
- Biocompatibility tests
-
- Catheter Integrity tests
No clinical testing was performed.
The results of the laboratory tests demonstrated that the device is safe, and as effective, if not more effective, as the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of three human profiles. The profiles are arranged in a way that they appear to be emerging from a single point. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 1998
Mr. Thomas D. Nickel Arrow International, Inc. 2400 Bernville Road Reading, PA 19605
Re: K982141 Arrow Balloon Embolectomy Catheter Regulatory Class: II (two) Product Code: DXE Dated: June 15, 1998 Received: June 17, 1998
Dear Mr. Nickel:
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 provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 regulation may result in regulatory 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 - Mr. Thomas D. Nickel
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"(21 CFR 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,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
P.O. Box 12888 Reading, PA 19612
Image /page/4/Picture/2 description: The image shows the word "ARROW" in large, bold, black letters. Below the word "ARROW" is the word "INTERNATIONAL" in smaller, thinner, black letters. The text is centered in the image. The background is white.
INTERNATIONAL
2400 Bernville Road Reading, PA 19605
(610) 378-0131 FAX: (610) 374-5360
SECTION 10. INDICATIONS
The Arrow Balloon Embolectomy Catheter is indicated for use as an accessory to the Arrow-Trerotola PTD™ Percutaneous Thrombolytic Device. It is intended to be used to remove the arterial plug from the arterial anastamosis of a thrombosed hemodialysis access graft.
Tu A.R.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
11982141 510(k) Number_