(4 days)
Not Found
No
The summary describes a mechanical thrombectomy catheter system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to remove thrombus (blood clots) from dialysis shunts, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as a thrombectomy catheter system, indicated for removing thrombus. This is a therapeutic action, not a diagnostic one. There is no mention of it being used to identify or characterize a disease or condition.
No
The device description clearly states it consists of a 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:
- Intended Use: The intended use is to "percutaneously remove soft, newly formed (≤ 5 days old) thrombus from dialysis shunts." This is a therapeutic procedure performed directly on the patient's body to treat a condition (thrombus).
- Device Description: The device is a catheter system designed for mechanical removal of thrombus. It involves injecting saline and removing fluid, which are actions performed within the patient's circulatory system.
- Lack of IVD Characteristics: IVDs are devices used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of specimens outside the body.
Therefore, the 7F Hydrolyser is a therapeutic medical device, not an IVD.
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 - 100 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The equivalence was confirmed through pre-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length)
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 shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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
Cordis Corp. Ariel MacTavish Senior Regulatory Affairs Associate 14201 N.w.60th Ave. Miami Lakes, Florida 33014
Re: K990805
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 March 15, 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 5 O'connell -S Date: 2021.10.08 10:43:35 -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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Ariel MacTavish, RAC Senior Regulatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K990805 Trade Name: Modification to 7F Hydrolyser Thrombectomy Catheter Requlatory Class: II Product Code: DXE Dated: March 10, 1999 March 11, 1999 Received:
Dear Ms. MacTavish:
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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 Reqister. Please note: this response to
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Page 2 - Ms. Ariel MacTavish
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 requlations.
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) 594-4586. 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 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. Callahan
Thomas J. Callahan, Ph. D. Director Division of Cardiovascular, Respiratory And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
్టాలు
Indications for Use Statement
| 510(k) Number (if known) | K990805 |
|---|---|
| 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)
Ch. To. Am. Awn
(Division Sign-O Division of Cardiovas and Neurological De 510(k) Number
Cordis 7F Hydrolyser Line Extension Special 510(k) March, 1999
4
Attachment 4
:
:"
Summary of Safety and Effectiveness
| General
| Provisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Cordis 7F Hydrolyser Thrombectomy Catheter | ||
| (65 – 100 cm length) | Embolectomy Catheter | |
| Name of | ||
| Predicate | ||
| Devices | The device is substantially equivalent to: | |
| • Cordis 7F Hydrolyser Thrombectomy Catheter (65 cm length) | ||
| 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 - 100 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 device. The equivalence was confirmed through pre-clinical | ||
| testing. | ||
| Cordis 7F Hydrolyser Line Extension | ||
| Special 510(k) | ||
| March, 1999 | 16 |