JMS Bypass Tube is intended to be used to internally shunt blood vessel during anastomosis constructions. The shunt allows blood to be delivered distally past the anastomosis site preventing ischemia while the target coronary artery is opened and surgical grafted to a donor vessel. The bypass shunt is to be removed prior to the final sutures being performed. Select the blood vessel bypass tube which is appropriate for the internal diameter of the blood vessel.

Device Description

The JMS Bypass Tube is a sterile, single use, consists of a tube shaft made by nylon with bulging bulbs at the distal ends. A guide-wire is inserted within the tube shaft to guide the easy insertion of tube shunt into target vessel. A tab on a thread is attached near to the mid-point of the flexible shaft. Each JMS Bypass Tube is individually packaged sterile and non-pyrogenic in a sealed, peel type pouch.

AI/ML Overview

The provided text describes the 510(k) summary for the JMS Bypass Tube, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with specific acceptance criteria as you might find for novel or AI-powered devices.

Therefore, many of the requested elements regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth are not applicable or not provided within this type of regulatory submission for this particular device.

Here's a breakdown of the information that is available and what is not:

Acceptance Criteria and Study Details for JMS Bypass Tube

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (as per document)
N/A - Not explicitly stated for performance metrics. The submission focuses on substantial equivalence to Baxter Research Medical, Inc.'s T-AnastaFLO (K990396).	"Non-clinical performance testing was conducted and had demonstrated that JMS Bypass Tube is safe and effective for use as intended and the device is substantially equivalent to existing predicate devices." "All materials used in JMS Bypass Tube conforms to FDA recognized consensus standard ISO 10993."

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

Sample Size: Not specified. The document refers to "non-clinical performance testing" but does not detail the number of units tested.
Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, JMS North America Corporation.

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

Not Applicable. This device is a physical medical instrument (a bypass tube), not a diagnostic AI or imaging device that requires expert ground truth for interpretation. The "ground truth" for this device would relate to its physical and material properties, and its ability to function as intended during a surgical procedure, which is evaluated through non-clinical testing and material compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

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:

Not Applicable. This is not an AI or imaging device that would involve human readers or AI assistance.

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

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable / Indirectly Implied: The "ground truth" for this device would be its adherence to established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional performance in non-clinical models (e.g., fluid flow, mechanical integrity). This is established through standard engineering and laboratory tests, not clinical outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set:

Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

Not Applicable. See point 8.

Summary of the Study Discussed:

The "study" described in the provided text is a collection of non-clinical performance tests focused on demonstrating the safety and effectiveness of the JMS Bypass Tube and its substantial equivalence to an existing predicate device (T-AnastaFLO, K990396).

Test Type: Non-clinical (likely bench testing, material compatibility testing).
Purpose: To confirm the device can perform its intended function (temporary bypass shunt to prevent ischemia during anastomosis) and meets material safety standards (ISO 10993).
Conclusion: The tests demonstrated the device is "safe and effective for use as intended and the device is substantially equivalent to existing predicate devices."

The 510(k) submission process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive clinical trial data with specific performance metrics and acceptance criteria for novel claims.

Summary

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510(K) Summary

Submitter / 510(K) Sponsor 1.

JMS North America Corporation. 22320 Foothill Blvd., Suite 350 Hayward, CA 94541 U.S.A.

Contact:	Swee Cheau, Chong
	Manager of Regulatory Affairs & Quality Assurance
Phone:	(510) 888-9090
Fax:	(510) 888-9099

Date Prepared: Sep 16, 2003

11. Device Name

Classification Name : Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification Number: 21 CFR 870.4210 Device Classification : Class II Device Trade Name : JMS Bypass Tube

III. Substantial Equivalence Predicate Device

Name	: T-AnastaFLO
510(K) Number	: K990396
Manufacturer	: Baxter Research Medical, Inc.
SE Decision Date	: Oct 1st, 1999

IV. Device Description

V. Intended Use

JMS Bypass Tube is indicated to be used to as temporary bypass shunt to internally shunt blood vessels during anastomosis constructions, hence preventing ischemia. The bypass shunt is to be removed prior to the final sutures being performed. The device is for single use only.

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VI. Safety and Effectiveness

Non-clinical performance testing was conducted and had demonstrated that JMS Bypass Tube is safe and effective for use as intended and the device is substantially equivalent to existing predicate devices. All materials used in JMS Bypass Tube conforms to FDA recognized consensus standard ISO 10993.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird-like figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 25 2004

JMS North America Corporation c/o Ms. Chong Swee Cheau Manager of Regulatory Affairs & Quality Assurance 22320 Foothill Blvd., Suite 350 Hayward, CA 94541

Re: K032977

JMS Bypass Tube Regulation Number: 21 CFR 870.4210 Regulation Name: Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: May 13, 2004 Received: May 14, 2004

Dear Ms. Chong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou mayy arous 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Chong Swee Cheau

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

Dona R. Vochnel

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K032977

Device Name: JMS Bypass Tube / Class II

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Yochner

(Division Sign-Off) (Division of Cardiovascular Devices

510(K) Number Ko32977

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).