(244 days)
Not Found
No
The device description and intended use describe a mechanical bypass tube with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a bypass tube used to divert blood flow during surgery, preventing ischemia. It does not actively treat a disease or condition but rather facilitates a surgical procedure.
No
The device is described as a bypass shunt used during surgical procedures to maintain blood flow and prevent ischemia. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly describes a physical medical device made of nylon with a guide-wire and packaging, indicating it is not software-only.
Based on the provided information, the JMS Bypass Tube is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "internally shunt blood vessel during anastomosis constructions." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical tube with bulbs and a guide-wire, designed for insertion into a blood vessel. This is a medical device used for intervention within the body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
The JMS Bypass Tube is a surgical device used in vivo (within the living body) during a surgical procedure, not for testing samples in vitro (outside the living body).
N/A
Intended Use / Indications for 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.
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.
Product codes
DWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels, target coronary artery
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
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.
1
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.
2
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.
3
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:
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.
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
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