(140 days)
Not Found
Not Found
No
The summary describes a mechanical thrombectomy catheter system that uses saline injection and fluid transport. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used to percutaneously remove thrombus, which is a treatment for a medical condition.
No
The device is described as a thrombectomy catheter system used to remove thrombus, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of a 7F Catheter and an Accessory Kit, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the 7F Hydrolyser is a catheter system used to percutaneously remove soft, newly formed thrombus from dialysis shunts. This is a therapeutic procedure performed directly on the patient's vascular system, not a test performed on a sample outside the body.
- Intended Use: The intended use is to remove thrombus, which is a treatment, not a diagnostic test.
Therefore, the 7F Hydrolyser is a medical device used for a therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts.
Product codes
QEZ, DXE
Device Description
The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of a 7F Catheter and an Accessory Kit.
The 7F Catheter is a 65 cm dual lumen catheter which consists of an injection lumen that allows for saline to be injected and an exhaust lumen that allows for the fluid to be transported into a collection bag.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dialysis shunts
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 equivalence was confirmed through pre-clinical and clinical testing.
Key Metrics
Not Found
Predicate Device(s)
Angiodynamics PRO™ Infusion Catheter, Arrow-Trerotola™ Percutaneous Thrombolytic Device Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The HHS logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" stacked above "ADMINISTRATION" in blue font.
October 8, 2021
Cordis Corp. Ariel MacTavish Sr. Regulatory Affairs Associate 14201 N.w.60th Ave. Miami Lakes, Florida 33014
Re: K983534
Trade/Device Name: Cordis 7F Hydrolyser Thrombectomy Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEZ
Dear Ariel MacTavish:
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 February 26, 1999. Specifically, FDA is updating this SE Letter 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(a)FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08 10:41:10 -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
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with three stylized wing segments.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 1999
Ariel MacTavish, RAC Senior Regulatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re : K983534 R983931
Trade Name: 7F Hydrolyser Thrombectomy Catheter Regulatory Class: II Product Code: DXE Dated: January 11, 1999 Received: January 12, 1999
Dear Ms. MacTavish:
We have reviewed your Section 510(k) notification of intent to market the we nave referenced above and we have determined the device is device referenced as a maications for use stated in the subscanctarly equivalent (195 entry marketed in interstate encrosure) to regarly manison the enactment date of the Medical Device Commerce prior co na cer that have been reclassified in accordance with Amendmentby, or oo ace al Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls may, chereises, maact. The general controls provisions of the Act provisions or one one 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 r four lor 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 Please note: this response to Federal Register.
2
Page 2 - Ms. Ariel MacTavish
your premarket notification submission does not affect any obligation you your premarked nocerrouseers in through 542 of the Act for devices under might nave under become one on the provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in IIIS fecter will arrow Jourseaus.
This fected will arrow Jourseling. The FDA finding of substantial your 510(K) premaired notifications in the expedicate device results equivalence of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation If you desire bpcording and additionally 809.10 for in vitro diagnostic (21 Crk Fart over and addressions)
devices), please contact the Office of Compliance at (301) 594-4586. devices), predbe consult on the promotion and advertising of your Additionally, 102 quobered on Compliance at (301) 594-4639. Also, action promote the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on premarked nover the Act may be obtained from the Division of your responsible to the 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. Callahan
Thomas J. Callahah Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 3
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Cordis 7F Hydrolyser Thrombectomy Catheter |
| Indications for Use | The 7F Hydrolyser is indicated to percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
Prescription Use _ (Per 21 CFR 801.109)
1
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
4
2/26/99
00-00028 K983134
Attachment 1
Summary of Safety and Effectiveness
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| General
| Provisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Cordis 7F Hydrolyser Thrombectomy Catheter | Embolectomy Catheter | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| Angiodynamics PRO™ Infusion Catheter used in conjunction with | ||
| a thrombolytic agent, such as Urokinase, in a pulse-spray | ||
| thrombolytic procedure Arrow-Trerotola™ Percutaneous Thrombolytic Device Catheter, in | ||
| conjunction with the Arrow Rotator Drive Unit | ||
| Classification | Class II. | |
| Performance | ||
| Standards | Performance standards have not been established by the FDA under | |
| section 514 of the Food, Drug and Cosmetic Act. | ||
| Indications for | ||
| Use | The 7F Hydrolyser is indicated to percutaneously remove soft, newly | |
| formed (≤ 5 days old) thrombus from dialysis shunts. | ||
| Device | ||
| Description | The Cordis 7F Hydrolyser Thrombectomy Catheter system consists of | |
| a 7F Catheter and an Accessory Kit. |
The 7F Catheter is a 65 cm dual lumen catheter which consists of an
injection lumen that allows for saline to be injected and an exhaust
lumen that allows for the fluid to be transported into a collection bag. | |
| Biocompatibility | All materials used in the Cordis 7F Hydrolyser Thrombectomy
Catheter are biocompatible. | |
| Summary of
Substantial
Equivalence | The Cordis 7F Hydrolyser Thrombectomy Catheter is substantially
equivalent to the predicate devices. The equivalence was confirmed
through pre-clinical and clinical testing. | |