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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MSD™ Embolectomy Basket, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical efficacy study. Therefore, the information provided primarily addresses safety and technical characteristics, and not extensive clinical performance data with specific acceptance criteria in the way a typical clinical trial would.

Based on the provided text, here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for clinical performance (e.g., a specific percentage of clot removal). Instead, it relies on demonstrating equivalence to predicate devices and proving safety through various tests.

However, we can infer some "performance" metrics and their comparison to the predicate device:

Parameter	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (MSD™ Embolectomy Basket)
Intended Use	Equivalent to predicate devices	Removing Arterial Emboli
Configuration	Safe and effective removal of emboli	Sock-shaped basket with mouth bonded to wire frame retractable into a delivery sheath
Deployed Diameter	Within clinically relevant range for emboli removal	Basket: 5 mm - 10 mm (For comparison, predicate balloon: 4 mm - 14 mm)
Catheter Length	Within clinically relevant range	65 cm - 120 cm (For comparison, predicate: 40 cm - 100 cm)
Biocompatibility	No issues relative to material safety	Performed by a licensed laboratory under GLP; results raised no issues relative to material safety.
Structural Adequacy	Forces required for operation are small; component separation forces exceed operational forces	Bench tests quantified; forces to operate were small; forces to separate components exceeded normal operational conditions.
Interactive Forces with Vessels	Equivalent to properly inflated predicate catheter	Animal studies showed Pinteraction forces equivalent to those experienced during use of a properly inflated Fogarty catheter. Measured force levels raised no safety issues.

2. Sample size used for the test set and the data provenance

Biocompatibility Tests: The exact number of samples tested is not specified, but it states "All prescribed biocompatibility tests for a device having short-term exposure to blood were performed." No information on the country of origin or whether it was retrospective/prospective is given, other than "performed by a licensed laboratory under GLP."
Bench Tests (Structural Adequacy): Not specified.
Animal Studies (Interactive Forces): Not specified. No information on the country of origin or whether it was retrospective/prospective is given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The studies described are primarily non-clinical (bench and animal) tests, not human-based clinical trials where expert ground truth would typically be established. Substantial equivalence claims often rely on comparing technical specifications and safety profiles to existing devices, reviewed by FDA experts.

4. Adjudication method for the test set

This information is not provided as it's not a clinical study with human observers or diagnostic outcomes requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no MRMC study mentioned. This device is an Embolectomy Basket, a mechanical intervention for clot removal, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an AI algorithm. The device is a physical medical instrument, an Embolectomy Basket. Therefore, this question is not applicable.

7. The type of ground truth used

Biocompatibility: In vitro and in vivo (animal, if applicable) laboratory assays validated against established safety standards.
Bench Testing: Engineering specifications and mechanical force measurements.
Animal Studies: Direct measurement of physical forces and comparison to established data (e.g., "data from studies in the peer-reviewed literature").

8. The sample size for the training set

This question is typically relevant for AI/ML models. Since this is a physical medical device, there is no training set for an algorithm.

9. How the ground truth for the training set was established

As there is no training set for an AI/ML algorithm, this question is not applicable.

Summary

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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

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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.

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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

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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)

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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 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

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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 AterialEmbolectoy Catheter
Intended Use	Removing Arterial Emboli	Removing Arterial Emboli
Configuration	Sock-shaped basket with mouthbonded to wire frame retractableinto a delivery sheath	Inflatable balloon bonded to acatheter shaft
Deployed Diameter ofBasket/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 Differentfrom Catheter andBasket/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.

Regulation Number and Section

§ 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).