(29 days)
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. This device is intended for sale by or on the order of a physician.
The JEM Series Endotracheal Tube Changer consists of an extruded open lumen, imprinted with graduated markings. The graduated markings are used as a guide for the successful replacement of a tracheal tube.
The provided text is a 510(k) Summary for JEM Endotracheal Tube Changers. It describes the device, its intended use, and the purpose of the 510(k) submission, which is to add ethylene oxide as an alternate sterilization method and to expand the user instructions.
However, the provided document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document is a Special 510(k) submission, which means it addresses minor changes to a previously cleared device. In such a submission, the focus is typically on demonstrating that the changes do not alter the substantial equivalence of the device, rather than conducting new performance studies against acceptance criteria for the core functionality. The original PMS submission (Premarket Approval of the JEM 400 in 1981) would have contained such data, but it is not included in this document.
Therefore, I cannot provide the requested information from the given text.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone algorithm performance study.
- The type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
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Section 5 – 510(k) Summary Special 510 (k) Submission Page 1 of 2
2990 Industrial Boulevard • Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com
AUG 2 7 2010
Date Prepared: July 23, 2010 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
SPECIAL 510(k) SUMMARY for JEM Endotracheal Tube Changers
| Trade Name | JEM 325, JEM 330, JEM 340, JEM 350, JEM 355,JEM 360, JEM 365, JEM 370, JEM 400 |
|---|---|
| CommonName | Changer, Tube, Endotracheal |
| ClassificationName | Accessory to Tracheal Tube |
| Regulation | 21 CFR 868.5730 |
| Purpose of510(k)submission | This Special 510(k) application is being submitted to notify the FDA of anintended update to the JEM Endotracheal Tube Changers User Instructions to:1. add ethylene oxide as a validated alternate sterilization method.2. and to expand the directions and pictorials in the User Instructionto assist our customers in the use of the JEM Endotracheal TubeChangers.At this time, we would also like to notify the FDA that the printing of the JEMEndotracheal Tube Changers is now done at our Bethel Park location. |
| PredicateDevice | No changes are being made to the devices, thus no Predicate Device is listed inthis summary.On September 30, 1980, the FDA ruled that there were no similar devices marketed in the US, thus Premarket Notification was not possible. After additional testing, correspondence and review, Premarket Approval of the JEM 400 was issued by the FDA in 1981. In 1999 eight additional sizes of |
| Page 2 of | |
| JEM tubes were granted approval through a PMA supplement. On December9, 2004, a letter from the FDA Office of Device Evaluation was receivedwhich stated that the JEM Series products were now subject to Class IIcontrols, rather than Class III. | |
| DeviceDescription | The JEM Series Endotracheal Tube Changer consists of an extruded openlumen, imprinted with graduated markings. The graduated markings are usedas a guide for the successful replacement of a tracheal tube. |
| Intended Useof the Device | JEM Series Endotracheal Tube Changers provide a simple, rapid technique forchanging endotracheal and orotracheal tubes, with specific inside diameters.JEM Series Endotracheal Tube Changers are intended for single patient use.This device is intended for sale by or on the order of a physician. |
| TechnologicalCharacteristics | The JEM Series Endotracheal Tube Changer consists of an extruded openlumen, imprinted with graduated markings. The length and diameters of theJEM Endotracheal Tube Changers are size specific and are notinterchangeable. Each JEM Endotracheal Tube Changer is extruded of highdensity polyethylene and is designed for a specific size of endotracheal tube asfollows:JEM 325 fits 2.5 mm I.D. endotracheal tubesJEM 330 fits 3.0 mm I.D. endotracheal tubesJEM 340 fits 4.0 mm I.D. endotracheal tubesJEM 350 fits 5.0 mm I.D. endotracheal tubesJEM 355 fits 5.5 mm I.D. endotracheal tubesJEM 360 fits 6.0 mm I.D. endotracheal tubesJEM 365 fits 6.5 mm I.D. endotracheal tubesJEM 370 fits 7.0 mm I.D. endotracheal tubesJEM 400 fits 7.5 mm I.D. endotracheal tubesJEM 401 is sold as a package containing one of each of the nine sizes. |
| Performance | Use of a JEM Endotracheal Tube Changer assists a health professional insafely changing out a used endotracheal tube for a fresh one in just a fewminutes. |
Image /page/0/Picture/7 description: The image shows the logo for Instrumentation Industries, Inc. The logo consists of a stylized graphic to the left of the company name. Below the company name is the tagline "We make Respiratory Care Work!"
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Doris Walter Regulatory Affairs/ Quality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102
AUG 2 7 2010
Re: K102127
Trade/Device Name: JEM Endotracheal Tube Changers Models JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400 Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: LNZ Dated: July 23, 2010 Received: July 29, 2010
Dear Ms. Walter:
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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Walter
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
hn for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices.and Radiological Health
Enclosure
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Section 4 - Indications for Use Special 510(k) Submission Page 1 of 1 -
Indications for Use
510(k) Number (if known):
Device Name:
JEM Endotracheal Tube Changers Models JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400
Statement of Indications for Use:
JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters.
JEM Series Endotracheal Tube Changers are intended for single patient use.
This device is intended for sale by or on the order of a physician.
V Prescription Use (Part 21 CFR 801 Subpart D) And/Or
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Schuttler
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Off) (Division Sign-Ult)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antonious - Onfection Control.
510(k) Number: K 102
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).