(630 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI/ML or related concepts like image processing, training data, or performance metrics typically associated with AI/ML devices.
Yes
The "MSD™ Embolectomy Basket" is designed for "removal of fresh, soft clot from vessels of the arterial system," which is a direct treatment aimed at restoring vessel patency.
No
This device is designed for the removal of clots (therapeutic), not for identifying or assessing a medical condition (diagnostic).
No
The device description clearly outlines multiple physical components made of materials like Nitinol and bio-compatible materials, indicating it is a hardware device.
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 Description and Intended Use: The description clearly states that the MSD™ Embolectomy Basket is a physical device used for the removal of fresh, soft clot from vessels of the arterial system. It is a mechanical tool that interacts directly with the body's internal structures.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples or performing any tests on them. Its function is purely mechanical.
Therefore, the MSD™ Embolectomy Basket falls under the category of a medical device used for therapeutic intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in removal of fresh, soft clot from vessels of the arterial system. NOT for use in the prevention of distal embolization during endovascular interventions. NOT for use in the carotid arteries.
Product codes
QEW, DXE
Device Description
The MSD™ Embolectomy Basket is a single use basket (not a ballon) for capture and removal of emboli. It has five components: a flexible sack of a bio-compatible material; a wire frame of shape-memory-effect alloy (specifically, Nitinol) in its superelastic state; a bio-compatible sheath; a wire linkage within the sheath connecting the frame to a handle.
The flexible, kink resistant wire linkage slides within the sheath. The proximal ends of both the sheath and the wire linkage are mounted to a handle. The distal end of the wire linkage is attached to the frame. The mouth of the sack, made of a thin, flexible material, is bonded to the loop formed by the frame.
The wire frame can be retracted into the sheath by operation of the handle. This process first closes the mouth of the sack and then configures it for retraction with the frame into the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels of the arterial system.
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
All tests were performed on packaged, sterilized units.
All prescribed biocompatibility tests for a device having short-term exposure to blood were performed by a licensed laboratory under GLP. Results raised no issues relative to material safety.
Bench tests experimentally quantified the structural adequacy of the device. Forces that the human hand must generate to operate the device were measured and shown to be small. Force levels to separate device components were measured. These were shown to exceed forces experienced by the device under normal operational conditions.
Animal studies were conduced to quantify interactive forces between the basket structure and vascular walls. These were equivalent to those experienced during use of a properly inflated Fogarty catheter. The data was also compared to dated from studies in the peer-reviewed literature. Measured force levels raised no safety issues.
Key Metrics
Not Found
Predicate Device(s)
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 logo of the U.S. Food and 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
Metamorphic Surgical Devices, LLC. Gerald Cano President & CEO 660 William Pitt Way Pittsburgh, Pennsylvania 15238
Re: K991093
Trade/Device Name: MSD Embolectomy Basket Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW
Dear Gerald Cano:
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 December 21, 2000. 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 -S O'connell -S Date: 2021.10.08 10:44:31 -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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. Inside the circle is a stylized image of a hand holding a caduceus, a symbol often associated with medicine and healthcare. The hand and caduceus are depicted in black, contrasting with the white background of the seal. The overall design suggests an official emblem related to health and human services in the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2000
Gerald Cano, Ph.D. President & CEO Metamorphic Surgical Devices, LLC 660 William Pitt Way Pittsburg, PA 15238
K991093 Re : MSD Embolectomy Basket Trade Name: Regulatory Class: II (two) Product Code: 74 DXE Dated: October 17, 2000 October 18. 2000 Received:
Dear Dr. Cano:
We have reviewed your Section 510(k) notification of intent to market we nave reviewed your booses and we have determined the device in the device forcioned and for the indications for use stated in the Substancially oqually marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Three State Commerce provices that have been reclassified MeGream Device Tuckens of the Federal Food, Drug, and In accordance with the primay, therefore, market the device, subject to Cosmeric nee (not) is provisions of the Act. The general controls che general controlo profisse requirements for annual registration, provisions of the now manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special II your device it class III (Premarket Approval), it may be subject to such Controls) of Class III (Fremains on regulations affecting your device additional concerer. Code of Federal Regulations, Title 21, Parts 800 can be round in the ially equivalent determination assumes compliance co oss. It babbeaned as a stacturing Practice requirements, as set with the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS General Icgaracton on Drug Administration (FDA) will verify such rnspections. Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this concerning your as reading submission submission does not affect any response of your gight have under sections 531 through 542 of the Act obrigation you might electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Gerald Cano, Ph.D.
This letter will allow you to begin marketing your device as described inis receir will arew on tification. The FDA finding of substantial in your 510(x) promazioice to a legally marketed predicate device equivalence of your device of a noge
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 regaration (21 ors), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and owertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). firer general information on your responsibilities under the Act may ocher general in the Division of Small Manufacturers Assistance at its be obtainsd 12cm 2000) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Dakartell
Adames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological. Health
Enclosure
3
510(k) Number (if known):_K991093
Device Name: MSD Embolectomy Basket
Indications For Use: For use in removal of fresh, soft clot from vessels of the arterial system. NOT for use in the prevention of distal embolization during endovascular interventions. NOT for use in the carotid arteries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dely Till
Division of Cardiovascular & Respiratory Devices
810(k) Number K991093
Prescription Use Only
(Optional Format 3-10-98)
4
Image /page/4/Picture/0 description: The image shows the date December 21, 2000. The month is represented by the abbreviation DEC. The day is 21 and the year is 2000. The text is in a simple, sans-serif font.
Image /page/4/Picture/1 description: The image shows the text 'K991093' in a handwritten style. The text is black and appears to be on a white background. The characters are connected, giving the impression of cursive writing.
Changing the tools of surgery
etamorphic Surgical Devices, LLC
Phone (412) 826-5300 Fax (412) 826-5301
Summary of Safety and Effectiveness Information [510(k) Summary]
| Submitter Information: | |
|---|---|
| Submitter's Name: | Metamorphic Surgical Devices, LLC |
| Address: | 660 William Pitt Way |
| Pittsburgh, PA 15238 | |
| Phone Number: | (412) 826-5300 |
| Fax Number: | (412) 826-5301 |
| Contact Person: | Gerald Cano, Ph.D. |
| Contact Person's Address: | 660 William Pitt Way |
| Pittsburgh, PA 15238 | |
| Date of Preparation: | March 26, 1999 |
| Device Name: | |
| Trade Name: | MSD™ Embolectomy Basket |
| Common/Usual Name: | Embolectomy Catheter |
| Classification Name: | Embolectomy Catheter |
| Predicate Device Name: | |
| Trade Name: | Fogarty® Thru-Lumen Embolectomy Catheter |
| Dual Lumen Embolectomy Catheter | |
| Biosensor Embolectomy Catheter |
Device desciption:
The MSD™ Embolectomy Basket is a single use basket (not a ballon) for capture and removal of emboli. It has five components: a flexible sack of a bio-compatible material; a wire frame of shape-memory-effect alloy (specifically, Nitinol) in its superelastic state; a bio-compatible sheath; a wire linkage within the sheath connecting the frame to a handle.
The flexible, kink resistant wire linkage slides within the sheath. The proximal ends of both the sheath and the wire linkage are mounted to a handle. The distal end of the wire linkage is attached to the frame. The mouth of the sack, made of a thin, flexible material, is bonded to the loop formed by the frame.
The wire frame can be retracted into the sheath by operation of the handle. This process first closes the mouth of the sack and then configures it for retraction with the frame into the sheath.
660 William Pitt Way . Pittsburgh, PA 15238
5
Intended Use:
The MSD™ Embolectomy Basket is for use in removal of fresh, soft clot from vessels of the arterial system. NOT for use in the prevention of distal embolization during of the arterial system. "NOT for use in the carotid arteries.
Technical Characteristics Summary:
| Parameter | MSD™ Embolectomy Basket | Baxter Fogarty Aterial
Embolectoy Catheter |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended Use | Removing Arterial Emboli | Removing Arterial Emboli |
| Configuration | Sock-shaped basket with mouth
bonded to wire frame retractable
into a delivery sheath | Inflatable balloon bonded to a
catheter shaft |
| Deployed Diameter of
Basket/Balloon | Basket: 5 mm - 10 mm | Balloon: 4 mm - 14 mm |
| Catheter Length | 65 cm -120 cm | 40 cm - 100 cm |
| Basket/ Balloon Material | Polyurethane | Latex |
| Catheter Material | PTFE | Polyvinylchloride |
| Bonding Material Different
from Catheter and
Basket/Balloon Material | No | Yes |
| Use of Inflation Liquid | No | Yes |
Performance Testing:
All tests were performed on packaged, sterilized units.
All prescribed biocompatibility tests for a device having short-term exposure to blood were performed by a licensed laboratory under GLP. Results raised no issues relative to material safety.
Bench tests experimentally quantified the structural adequacy of the device. Forces that the human hand must generate to operate the device were measured and shown to be this namall hand mast good ty. Force levels to separate device components were measured. These were shown to exceed forces experienced by the device under normal operational conditions.
Animal studies were conduced to quantify interactive foces between the basket structure and vascular walls. These were equivalent to those experienced during use of a properly inflated Fogarty catheter. The data was also compared to dated from studies in the peer-reviewed literature. Measured force levels raised no safety issues.