(426 days)
K 831720
K 831720
No
The device description and performance studies focus on the physical characteristics and functional testing of a tracheostomy tube, with no mention of AI or ML capabilities.
Yes
The device is intended to permit conventional ventilation and spontaneous ventilation, which are therapeutic interventions.
No
The device is described as an intervention tool for ventilation, suctioning, and spontaneous ventilation, used after insertion in an incision at the cricothyroid space for emergency surgical cricothyrotomy. Its function is to facilitate air passage, not to provide diagnostic information.
No
The device description clearly indicates it is a physical medical device made of flexible medical grade PVC, designed for insertion into the cricothyroid space. It describes physical features like a beveled tip, radiopaque line, and available sizes, and mentions physical performance tests like inflation/deflation and sterilization validation. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical intervention (emergency surgical cricothyrotomy) to establish an airway for ventilation and suctioning. This is a direct medical procedure performed on a patient.
- Device Description: The device is a physical tube designed to be inserted into the body.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic and life-support device used directly on the patient.
N/A
Intended Use / Indications for Use
The intended use of this device is to permit conventional ventilation, suctioning, and spontaneous ventilation on the part of an adult patient after insertion of the device in an incision at the cricothyriod space.
The Tracheony Tube for Emergency Cricothyrotomy is intended for emergency surgical crioothyrotomy.
Product codes
73 BTO
Device Description
- · Polamedco's Tracheostomy Tube for Emergency Cricothyrotomy is designed for use by EMT's, Paramedics, E.R. Physicians, Anesthesiologists and R.N.'s
- · The length of the device is longer than a tracheostomy tube with comparable internal diameter/outside diameter
- · The device features a beveled smooth rounded tip that minimizes trauma
- · The device is made of flexible medical grade PVC
- · Features full radiopaque line for tube depth visualization
- · Packaged Sterile and single use
- · Latex Free
- · The device is made with heavy metal free materials that are safe incinerate and autoclave
- · Available in: 5.5 mm., 6.0 mm and 6.5 mm. ID sizes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cricothyriod space
Indicated Patient Age Range
adult patients and children above 8 years of age
Intended User / Care Setting
EMT's, Paramedics, E.R. Physicians, Anesthesiologists and R.N.'s
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)
The following tests are to assure safety and effectiveness of Polamedco, Inc. Tracheostomy Tube for Emergency Cricothyrotomy:
- In-house inflation and deflation test
- Functional test during manufacturing
- Sterilization validation
- Other applicable qualifying tests
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 831720
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
OCT 27 1999
POLAMEDCO, INC. 4054 GLENCOE AVENUE MARINA DEL REY, CA 90592-5608 PHONE: (310) 577-1422 (800) 227-7578 FAX: (310) 277-1426
Page 1 of 2 510 (K) Summary
510 (K) SUMMARY POLAMEDCO Tracheostomy Tube for Emergency Cricothyrotomy
| Date: | June 25,1999 |
|---|---|
| Owner/Operator: | Polamedco, Inc. |
| 4054 Glencoe Avenue | |
| Marina del Rey, CA 90292 | |
| Registration # 2020839 | |
| Device Trade Name: | Tracheostomy Tube for Emergency Cricothyrotomy |
| Common Name: | Tracheostomy Tube for Emergency Cricothyrotomy |
| Classification Name: | Class 2 |
| Regulatory Reference: | K 983000 |
| Predicate Device: | Kendall Argyle Tracheostomy tube "substantially equivalent to |
| devices introduced into interstate commerce prior to | |
| May 28, 1976", Ref:K 831720 |
Description:
- · Polamedco's Tracheostomy Tube for Emergency Cricothyrotomy is designed for use by EMT's, Paramedics, E.R. Physicians, Anesthesiologists and R.N.'s
- · The length of the device is longer than a tracheostomy tube with comparable internal diameter/outside diameter
- · The device features a beveled smooth rounded tip that minimizes trauma
- · The device is made of flexible medical grade PVC
- · Features full radiopaque line for tube depth visualization
- · Packaged Sterile and single use
- · Latex Free
- · The device is made with heavy metal free materials that are safe incinerate and autoclave
- · Available in: 5.5 mm., 6.0 mm and 6.5 mm. ID sizes
1
Intended Use:
· The intended use of this device is to permit conventional ventilation, suctioning, and spontaneous ventilation on the part of an adult patient after insertion of the device in an incision at the cricothyriod space.
Physical/Technical Comparison:
Similarities:
- · have the same intended use which is to establish ventilation or airway
- · both devices are for use on adult patients and children above 8 years of age
- are both latex free
- · are both safe to incinerate and or autoclave
- · both are preconnected to 15 mm connectors
- · the POLAMEDCO device has a full radiopaque line for tube depth visualization; the Arglye device is radiopaque.
- · both packaged sterile and disposable for single use
- · the devices feature a beveled smooth rounded tip that minimizes trauma
- both devices are for use in children and adults
- · both devices do not include or require stylets for use
- · both are flexible
- · both are unshortened
DIFFERENCES:
• The length of the device is longer than a tracheostomy tube with comparable internal diameter/ outside diameter
Performance Summary:
The following tests are to assure safety and effectiveness of Polamedco, Inc. Tracheostomy Tube for Emergency Cricothyrotomy:
- In-house inflation and deflation test ●
- Functional test during manufacturing .
- Sterilization validation ●
- Other applicable qualifying tests .
Reference Standards:
- · Federal Register 43June 1978 Proposed Residual Limits for ETO, ECH and ETG.
- · Sterilization Exposed to sub process Treatment, ISO 11737-97 Appendix 1-4
- · 21 CFR 821 June 23,1978 and ANSI/AAMI/ISO 10993-7: 1995
- · ANSI/AAMI/ISO 11135: 1994 Guideline for Industrial Ethylene Oxide Sterilization Medical Devices
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 1999
Gerald S. Linder, M.D. Polamedco, Inc. 4054 Glencoe Avenue Marina Del Rey, CA 90292-5608
Re : K983000 Cricothyrotomy Tube Regulatory Class: II (two) Product Code: 73 BTO Dated: July 1, 1999 Received: August 26, 1999
Dear Dr. Linder:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 regulations.
Image /page/2/Picture/9 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird or abstract human figure.
3
Page 2 - Gerald S. Linder, M.D.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
farmer H. Westerhausen for,
Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
POLAMEDCO, INC 4054 GLENCOE AVENUE MARINA DEL REY, CA 90292-5608 PHONE: (310) 577-1422 (310) 577-1426 FAX: FAX: 1
Indication For Use
510 (k) Number K983000
Indication For Use:
The Tracheony Tube for Emergency Cricothyrotomy is intended for emergency surgical crioothyrotomy. :
Prescription use per 21 CFR 601.109
.OR
Oversthe-Counter Use
(PERSEN NEEDED)
Concurrunge of CDRH Office of Device Evaluation (ODE)
(Division Siga-m
Division of Cardiovascutar. Respiratory,
and Ne
510(k) Number: K983000
: