The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyrogenic. The device is transvascularly deployed to the right ventricle of the heart for the acquisition of endomyocardial tissue samples Typically, the approach is made from the jugular vein or femoral arteries. The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Endomyocardial Biopsy Forceps (EMB) manufactured by Medcanica, Inc. It seeks to establish substantial equivalence to a predicate device, the BiPal Biopsy Forceps from Cordis Corporation (510(k) K914567).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, measurable format with corresponding "reported device performance" in the way one might expect for a diagnostic or AI device study. Instead, it focuses on demonstrating substantial equivalence to a predicate device through shared technological characteristics and compliance with recognized consensus standards.

The closest representation of "acceptance criteria" and "performance" can be inferred from the comparison table of technological characteristics and the declaration of compliance with standards.

Feature / Criteria (Implied)	Predicate Device (Assumed "Acceptance Criteria" for Equivalence)	EMB (Reported Device Performance)
Technological Characteristics
510(k) Number	K914567	To be determined (K991486 granted post-submission)
Manufacturer	Cordis Corporation	Medcanica, Inc.
Sterile packaging	Mylar®/Tyvek® Pouch, Box	Mylar®/Tyvek® Pouch, Box
Sterilization method	Ethylene Oxide	Ethylene Oxide
Single Use	Yes	Yes
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Shelf life	3 years	1 year initially, 3 years subsequent to accelerated aging tests
Intended use	Designed for endomyocardial biopsies	Designed for endomyocardial biopsies
Formable tip	Yes	Yes
Radiopaque	Yes	Yes
Available Sizes	5.4 and 7.0 French	5.4 and 7.0 French
Working lengths (cm)	50 and 104	50 and 105
Jaw action	Double-action (both jaws move)	Double-action (both jaws move)
Tip curve orientation marker	Handle Logo	Handle Logo
Recirculating Blood Contact outer sheath	Teflon®, (PTFE)	Teflon®, (FEP)
Recirculating Blood Contact Metallic Parts	Stainless Steel	Stainless Steel
Color Coding	Yes	Yes
Jaw Size Indication	Strain Relief Logo	Handle Logo
Handle	3-ring pull type	3-ring pull type
F5.4 minimum recommended sheath size (French)	6	6
F7.0 recommended sheath size (French)	7	7
Calculated (Labeled) Jaw Volume 5.4 F (mm³)	1.84	2.20
Calculated (Labeled) Jaw Volume 7.0 F (mm³)	5.03	5.20
Compliance with Standards
ASTM F899 95 (Stainless Steel for Surgical Instruments)	Not explicitly stated for predicate, but assumed	EMB meets requirements
ANSI/AAMI/ISO 10993-7:1995 (Ethylene oxide sterilization residuals)	Not explicitly stated for predicate, but assumed	EMB meets requirements
ANSI/AAMI/ISO 11135-1994 (EO Sterilization Validation/Control)	Not explicitly stated for predicate, but assumed	EMB complies with standards
21 CFR, § 821.100 (EO, ECH, EG Proposed Maximum Residue Limits)	Not explicitly stated for predicate, but assumed	EMB complies with standards

The general acceptance criterion is "substantial equivalence" to the predicate device. The performance is demonstrated by the device sharing similar technological characteristics and meeting the cited consensus standards, indicating that it performs "as well as or better than the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document primarily describes bench testing for the EMB device to demonstrate substantial equivalence. It does not refer to a "test set" in the context of a dataset of cases or clinical images.

Sample Size for Test Set: Not applicable in the context of image analysis or AI. The testing described is for the physical device itself. The specific number of devices tested for tensile, flexibility, dimensional, and performance tests is not quantified in the provided text.
Data Provenance: Not applicable. The "data" refers to the results of bench tests on the physical device, not patient data or clinical images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this document. The device in question is a physical endomyocardial biopsy forceps, not a diagnostic algorithm or AI system that requires expert-established ground truth from images or patient data. The "ground truth" here would be the physical properties and performance characteristics of the device under specific testing conditions, measured by engineering methods.

4. Adjudication Method for the Test Set

This information is not applicable to this document, as there is no "test set" of cases/images requiring expert adjudication in the context of a 510(k) for a physical medical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study relates to the performance of diagnostic algorithms or AI systems and their impact on human reading, which is not relevant to a physical biopsy forceps.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of the EMB device is established through bench test results against engineering specifications and comparison to the characteristics of the predicate device. This includes:

Dimensional measurements: Jaw volume, working lengths, sizes.
Material properties: Compliance with ASTM F899 95 for stainless steel.
Biocompatibility: Through selection of materials with a "long history of biocompatibility" and compliance with ISO 10993-7 for sterilization residuals.
Sterilization efficacy: Compliance with ANSI/AAMI/ISO 11135-1994 and 21 CFR, § 821.100 regarding ethylene oxide sterilization.
Functional performance: "Tensile, flexibility, and performance tests" demonstrating similar function to the predicate device.

Essentially, the ground truth is established by direct physical and chemical testing of the device and its components against established engineering and regulatory standards, and by comparison to the known characteristics of the legally marketed predicate device.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design and manufacturing process are guided by engineering principles, regulatory standards, and the characteristics of the predicate device.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI/machine learning model. For the device itself, the design and manufacturing are founded on established engineering principles, materials science, and medical device regulations. Compliance with Good Manufacturing Practices (GMP) and the Quality System Regulation (QS) for Medical Devices (21 CFR Part 820) ensure the device is safe and effective.

Summary

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Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K' followed by the numbers '991486'. The numbers are written in a cursive style, and there is a line underneath the sequence.

of Safety and Effect for the Endomyocardial Cardiac Biops

NOV - 5 1999

Submitted by

Medcanica, Inc. 8308 NW 74th Avenue Miami, FL 33166 Phone: (305) 863-1603

Identification of a Legally Marketed Predicate Device

The Medcanica, Inc. Endomyocardial Biopsy Forceps (EMB) is substantially equivalent to the BiPal Biopsy Forceps manufactured and marketed by the Cordis Corporation pursuant to 510(k) K914567.

General Description

The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws. A typical EMB is shown in Figure 1, EMB (Jaws Open). Details of the jaws are shown separately in Figure 2, Jaw Assembly.

Image /page/0/Figure/12 description: The image shows a medical instrument, possibly a biopsy tool or a similar surgical device. It features a long, slender shaft with a grasping or cutting mechanism at one end. The handle is complex, with multiple loops and levers, suggesting a design for precise control and manipulation during medical procedures.

Figure 1, EMB (Jaws Open)

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Image /page/1/Picture/2 description: The image shows a technical drawing of a mechanical arm or gripper. The arm consists of a cylindrical body connected to a set of hinged jaws. The jaws are open, revealing their curved inner surfaces. The drawing is done in a simple line style, with no shading or color.

Figure 2, Jaw Assembly

Intended Use

ﺮ

The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.

Summary of Technological Characteristics

The table below compares the technological characteristics of the EMB to the predicate device.

Feature	EMB	Predicate Device
510(k) Number	To be determined	K914567
Manufacturer	Medcanica, Inc.	Cordis Corporation
Sterile packaging	Mylar®/Tyvek® Pouch, Box	Mylar®/Tyvek® Pouch, Box
Sterilization method	Ethylene Oxide	Ethylene Oxide
Single Use	Yes	Yes
Pyrogenicity	Non-pyrogenic	Non-pyrogenic
Shelf life	1 year initially, 3 years subsequent toaccelerated aging tests	3 years
Intended use	The Endomyocardial Biopsy For-ceps are designed for endomyocar-dial biopsies.	The Cordis biopsy forceps are de-signed for endomyocardial biopsies.
Formable tip	Yes	Yes
Radiopaque	Yes	Yes
Available Sizes	5.4 and 7.0 French	5.4 and 7.0 French
Working lengths (cm)	50 and 105	50 and 104
Jaw action	Double-action (both jaws move)	Double-action (both jaws move)

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Feature	EMB	Predicate Device
Tip curve orientation marker	Handle Logo	Handle Logo
Recirculating Blood Contact outer sheath	Teflon®, (FEP)	Teflon®, (PTFE)
Recirculating Blood Contact Metallic Parts	Stainless Steel	Stainless Steel
Color Coding	Yes	Yes
Jaw Size Indication	Handle Logo	Strain Relief Logo
Handle	3-ring pull type	3-ring pull type
F5.4 minimum recommended sheath size (French)	6	6
F7.0 recommended sheath size (French)	7	7
Calculated (Labeled) Jaw Volume 5.4 F (mm³)	2.20	1.84
Calculated (Labeled) Jaw Volume 7.0 F (mm³)	5.20	5.03

Summary of Performance Data

The EMB meets the requirements of the following recognized consensus standards.

ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar and Wire . for Surgical Instruments
Biological Evaluation of Medical Devices-Part 7: Ethylene oxide sterilization . residuals, American National Standard, ANSI/AAMI/ISO 10993-7:1995
. Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization, ANSI/AAMI/ISO 11135-1994, Approved March 24, 1994 by the American National Standards Institute, Inc.

Additionally, the EMB complies with the following standards:

Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol, Proposed Maximum . Residue Limits and Maximum Levels of Exposure, 21 CFR, § 821.100, Proposed Rule, June 23, 1978.
The EMB is substantially equivalent to the cardiac biopsy forceps manufactured and marketed by the Cordis Corporation pursuant to 510(k) K914567. Extensive bench testing of

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both devices has demonstrated this. Testing includes tensile, flexibility, dimensional, and performance tests. Furthermore, the device has similar technological characteristics to Cordis cardiac biopsy forceps.

The recirculating blood contact materials of the device have been carefully selected for their long history of biocompatibility.

Since the EMB meets the requirements of the stated standards and embodies technological characteristics essentially identical to those of the predicate device, we believe the device is safe and effective and that it performs as well as or better than the predicate device. The device has been designed and developed utilizing design control methods in compliance with the GMP. The EMB will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines, possibly representing people or services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 1999 HOV

Mr. Matthew A. Palmer President Medcanica, Inc. 19526 E. Lake Drive Miami, FL 33015

Re : K991486 ULTRA-CBX Requlatory Class: II (Two) Product Code: DWZ Dated: August 6, 1999 Received: Auqust 9, 1999

Dear Mr. Palmer:

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 reqistration, 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 Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to 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.

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Page 2 - Mr. Matthew A. Palmer

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C. Bogdon for

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Page 1 of 1

510(k) Number (if known): K991486

Device Name Endomyocardial Biopsy Forceps

Indications for Use:

— The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kare R. Lamperle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

K991486 510(k) Number _

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use No

(Optional Format 1-2-96)

Page 4 of 3

Regulation Number and Section

§ 870.4075 Endomyocardial biopsy device.

(a)
Identification. An endomyocardial biopsy device is a device used in a catheterization procedure to remove samples of tissue from the inner wall of the heart.(b)
Classification. Class II (performance standards).