(201 days)
Not Found
No
The description focuses on the mechanical action of the device (spinning basket to pulverize clot) and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is used for mechanical declotting, which is a therapeutic intervention aimed at treating medical conditions (clotting in fistulae and grafts).
No
The device is described as a "Percutaneous Thrombolytic Device" used for "mechanical declotting." Its function involves physically fragmenting and aspirating clots, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details physical components like a catheter, torque cable, fragmentation basket, and a Rotator Drive Unit, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mechanically declot native arterio-venous fistulae and synthetic dialysis grafts. This is a therapeutic procedure performed directly on the patient's body to treat a physical condition (blood clots).
- Device Description: The device is a catheter with a mechanical fragmentation basket designed to physically break up blood clots within blood vessels. It is used in conjunction with a drive unit to perform this mechanical action.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of biological specimens.
The device is a medical device used for a therapeutic intervention within the patient's vascular system.
N/A
Intended Use / Indications for Use
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.
Product codes (comma separated list FDA assigned to the subject device)
QEW, DXE
Device Description
The Arrow-Trerotola™ PTD™ Catheter Assembly consists of two components, an outer cover sheath and an inner flexible torque cable with a self-expanding fragmentation basket attached to its distal end. The PTD™ fragmentation basket is constructed of four wires that are formed into a helical cage with a soft, flexible tip located on its distal end. The PTD™ catheter is designed to be used in conjunction with the Arrow Rotator Drive Unit that spins the basket at approximately 3000rpm. A drive hub on the proximal end of the catheter assembly mates with a drive gear in the Rotator Drive Unit. The cable stop on the catheter assembly secures the PTD™ Catheter to the Rotator Unit during operation.
The PTD™ outer sheath moves relative to the inner torque cable and is used to collapse and expand the fragmentation basket. The catheter is placed inside the clotted fistula with the basket in the closed position. After insertion, the basket is fully deployed inside the fistula to conform to the fistula wall. The basket is then rotated which pulverizes the clot; the clot is aspirated from the graft through an introducer sheath.
The PTD™ catheter is manufactured in two lengths, 65cm and 120cm, with a basket diameter of 9mm. It is also available in an Over-The-Wire (OTW) version, which allows the device to be passed over a guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native arterio-venous fistulae and synthetic dialysis grafts.
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 expanded indications for use to include native arterio-venous fistulae is based on the clinical data presented in the performance section of the submission.
The Arrow-Trerotola™ PTD™ is as safe and effective as the legally marketed predicate device for the mechanical declotting of native arterio-venous fistulae.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Arrow Intl., Inc. Thomas Nickel Vice President RA 2400 Bernville Rd. Reading, Pennsylvania 19605
Re: K011056
Trade/Device Name: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
Dear Thomas Nickel:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 24. 2001. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell - o'connell -s Date: 2021.10.08 S 10:17:52 -04'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." arranged in a circular pattern around the symbol. The logo is black and white.
OCT 2 4 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International 2400 Bernsville Road Reading, PA 19605
Re: K011056
Trade Name: Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II (two) Product Code: DXE Dated: July 27, 2001 Received: July 31, 2001
Dear Mr. Nickel:
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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The rou may, increase or visions 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 (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.
2
Page 2 - Mr. Thomas D. Nickel
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 of 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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
R. James E. Dillard III
James B. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification: Arrow-Trerotola™ Percutaneous Thrombolytic Device
SECTION 12. INDICATIONS FOR USE STATEMENT
KO11056 510(k) Number
Device Name: Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™)
Indications For Use: The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011056
4
KOII056
OCT 2 4 2001
510(k) Premarket Notification: Arrow-Trerotola™ Percutaneous Thrombolytic Device
SECTION 2. 510(K) SUMMARY
P.O. Box 12888 Reading, PA 19612
ARROW
INTERNATIONAL
Submitter
Arrow International 2400 Bernville Road Reading, PA 19605
Research/Engineering 2400 Bernville Road Reading, PA 19605
(610) 378-0131 FAX: (610) 478-3188
Contact person:
Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Phone: (610) 478-3137 (610) 478-3172 Fax: E-mail: tom.nickel@arrowintl.com
04/03/01 Date summary prepared:
Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Device trade name:
Thrombolytic device, thrombolytic catheter and PTD™ Device common name:
Class II at 21 CFR 870.5150, Embolectomy catheter Device classification
name:
Legally marketed devices to which the device is substantially equivalent:
Arrow-Trerotola™ Percutaneous Thrombolytic Device K990829
Description of device
The Arrow-Trerotola™ PTD™ Catheter Assembly consists of two components, an outer cover sheath and an inner flexible torque cable with a self-expanding fragmentation basket attached to its distal end. The PTD™ fragmentation basket is constructed of four wires that are formed into a helical cage with a soft, flexible tip located on its distal end. The PTD™ catheter is designed to be used in conjunction with the Arrow Rotator Drive Unit that spins the basket at approximately 3000rpm. A drive hub on the proximal end of the catheter assembly mates with a drive gear in the Rotator Drive Unit. The cable stop on the catheter assembly secures the PTD™ Catheter to the Rotator Unit during operation.
The PTD™ outer sheath moves relative to the inner torque cable and is used to collapse and expand the fragmentation basket. The catheter is placed inside the clotted fistula with the basket in the closed position. After insertion, the basket is fully deployed inside the fistula to conform to the fistula wall. The basket is then rotated which pulverizes the clot; the clot is aspirated from the graft through an introducer sheath.
The PTD™ catheter is manufactured in two lengths, 65cm and 120cm, with a basket diameter of 9mm. It is also available in an Over-The-Wire (OTW) version, which allows the device to be passed over a guidewire.
5
510(k) Premarket Notification: Arrow-Trerotola™ Percutaneous Thrombolytic Device
Intended use of the device:
The Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD™) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous fistulae and synthetic dialysis grafts.
Technological characteristics:
The proposed device has the same technological characteristics as the predicate device.
Performance tests:
The expanded indications for use to include native arterio-venous fistulae is based on the clinical data presented in the performance section of the submission.
Conclusions:
The Arrow-Trerotola™ PTD™ is as safe and effective as the legally marketed predicate device for the mechanical declotting of native arterio-venous fistulae.