(29 days)
None
Not Found
No
The summary describes a simple mechanical device with graduated markings and does not mention any AI or ML components or functionalities.
No
The device is designed to assist in replacing endotracheal tubes, not to treat a disease, injury, or condition itself. It's a tool for a medical procedure rather than a therapeutic intervention.
No
The device description and intended use clearly state its purpose is for changing endotracheal and orotracheal tubes, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly states it "consists of an extruded open lumen, imprinted with graduated markings," which describes a physical, hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the changing of endotracheal and orotracheal tubes. This is a procedure performed directly on a patient, not on a sample taken from a patient.
- Device Description: The device is a physical tool (an extruded open lumen) used for a procedural purpose. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
The JEM Series Endotracheal Tube Changer is a medical device used in a clinical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes
LNZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Use of a JEM Endotracheal Tube Changer assists a health professional in safely changing out a used endotracheal tube for a fresh one in just a few minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
No changes are being made to the devices, thus no Predicate Device is listed in this summary.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common
Name | Changer, Tube, Endotracheal |
| Classification
Name | Accessory to Tracheal Tube |
| Regulation | 21 CFR 868.5730 |
| Purpose of
510(k)
submission | This Special 510(k) application is being submitted to notify the FDA of an
intended update to the JEM Endotracheal Tube Changers User Instructions to:
- add ethylene oxide as a validated alternate sterilization method.
- and to expand the directions and pictorials in the User Instruction
to assist our customers in the use of the JEM Endotracheal Tube
Changers.
At this time, we would also like to notify the FDA that the printing of the JEM
Endotracheal Tube Changers is now done at our Bethel Park location. |
| Predicate
Device | No changes are being made to the devices, thus no Predicate Device is listed in
this 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 December
9, 2004, a letter from the FDA Office of Device Evaluation was received
which stated that the JEM Series products were now subject to Class II
controls, rather than Class III. |
| Device
Description | 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. |
| Intended Use
of the Device | 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. |
| Technological
Characteristics | The JEM Series Endotracheal Tube Changer consists of an extruded open
lumen, imprinted with graduated markings. The length and diameters of the
JEM Endotracheal Tube Changers are size specific and are not
interchangeable. Each JEM Endotracheal Tube Changer is extruded of high
density polyethylene and is designed for a specific size of endotracheal tube as
follows:
JEM 325 fits 2.5 mm I.D. endotracheal tubes
JEM 330 fits 3.0 mm I.D. endotracheal tubes
JEM 340 fits 4.0 mm I.D. endotracheal tubes
JEM 350 fits 5.0 mm I.D. endotracheal tubes
JEM 355 fits 5.5 mm I.D. endotracheal tubes
JEM 360 fits 6.0 mm I.D. endotracheal tubes
JEM 365 fits 6.5 mm I.D. endotracheal tubes
JEM 370 fits 7.0 mm I.D. endotracheal tubes
JEM 400 fits 7.5 mm I.D. endotracheal tubes
JEM 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 in
safely changing out a used endotracheal tube for a fresh one in just a few
minutes. |
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!"
1
.
2
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.
3
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
4
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