(305 days)
The indication for use for all the product variants is grouped into three different sections:
(a) Uncuffed, oral/nasal and Cuffed, oral /nasal:
The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management.
(b) Uncuffed, nasal only and Cuffed, nasal only:
The intended use of this device is to be intubated into a patient's trachea via the nose for airway management, specifically for use in surgical procedures involving the head, neck and face.
(c) Uncuffed, oral only and Cuffed, oral only:
The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.
Tiger Medical Products Ltd's Endotracheal tube is available in 90 different variants distributed among 6 main configurations and different sizes, as detailed below. It is marketed as sterile, single use, for airway management.
It consists of a clear tracheal tube with radiopaque blue stripe running its entire length, and it is graduated with multiple centimeter markings to allow easy detemination of intubated length, and is terminated with a 15mm standard connector.
It conforms to ISO 5261: 1999 and ASTM F1242: 1996 with one minor exception in the tube marking.
The six categories (or confiqurations) are listed below:
-
(a) CATEGORY 1: uncuffed, oral/nasal:
It is provided as uncuffed, murphy, oral/nasal, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes -
(b) CATEGORY 2: uncuffed, nasal only:
It is provided as uncuffed, murphy, preformed nasal- 2 eyes, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes -
(c) CATEGORY 3: uncuffed, oral only:
It is provided as uncuffed, murphy, preformed oral- 2 eyes, and it is provided as anones from sizes 2.0 to 10.0 inclusive, totalling 17 sizes -
(d) CATEGORY 4: cuffed, oral/nasal:
lt is provided as cuffed, murphy, oral/nasal, and in 0.5mm ID it is provided as sizes 4.0 to 10.0 inclusive, totalling 13 sizes -
(e) CATEGORY 5: cuffed, nasal only:
It is provided as cuffed, murphy, preformed nasal, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes -
(f) CATEGORY 6: cuffed, oral only:
lt is provided as cuffed, murphy, preformed oral, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes
The provided text describes a 510(k) summary for Tiger Endotracheal tubes, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, many of the requested sections about acceptance criteria and study details cannot be directly extracted or inferred from this document. The document argues for substantial equivalence based on similarity in design, materials, performance, and other characteristics, rather than by presenting new performance data against numerical thresholds.
Here's a breakdown of what can be gathered and what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary does not outline specific numerical acceptance criteria (e.g., tensile strength minimums, cuff pressure retention rates) or present a study showing the Tiger Endotracheal tubes met such criteria with quantified performance metrics. Instead, it relies on a qualitative comparison of "TECHNOLOGICAL CHARACTERISTICS" to predicate devices, stating conclusions like "Identical" or "Similar."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document makes no mention of a "test set" in the context of a performance study, nor does it refer to sample sizes used for testing. The primary focus is on comparing the technological characteristics of the new device to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not provided. There is no mention of a performance study requiring expert review or ground truth establishment for a test set.
4. Adjudication Method
This information is not applicable/not provided. As no expert-reviewed test set is mentioned, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable/not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a physical medical device (endotracheal tube), not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable/not provided. This is a physical device, not an algorithm, so a standalone performance study in that context is not relevant. The information provided is for regulatory clearance based on substantial equivalence.
7. Type of Ground Truth Used
This information is not applicable/not provided. Since no performance study generating new data for assessing ground truth is described, this detail is not relevant to the document's content. The document relies on the established safety and effectiveness of predicate devices as a basis for its claims.
8. Sample Size for the Training Set
This information is not applicable/not provided. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As there is no training set mentioned, there is no ground truth establishment process described for it.
In summary: The provided document is a 510(k) summary for a medical device (endotracheal tubes), which aims to demonstrate "substantial equivalence" to existing, legally marketed predicate devices. This regulatory pathway typically involves comparing the new device's design, materials, intended use, and technological characteristics to the predicate, rather than conducting new clinical trials or extensive performance studies with quantitative acceptance criteria and ground truth establishment in the manner that would be expected for a novel diagnostic or AI-powered device. The document explicitly states: "This device is safe and effective as the predicate device cited above."
{0}------------------------------------------------
MAR 1 8 2005 510(k) Summary As Required by 21 section 807.92 ( c )
1-Submitter Name: TIGER MEDICAL PRODUCTS LTD
2-Address: Liu Lin Tower, Suite 1910. 1 Huai Hai Zhong Road. Shanghai 200021 CHINA
3-Phone: +86-21-6386-6300
+86-21-5383-5200 4-Fax:
Mark Engel, President 5-Contact Person:
6-Date summary prepared: April 15th, 2004
7 - Official Correspondent: TIGER REGULATORY
1308 Morningside Park Dr. Alpharetta, GA 30022 USA 8- Address:
9- Phone: (770) 777-4146
10- Fax (678) 623- 3765
11- Contact person: Jay Mansour
12-Device Trade or Proprietary Name: Tiger Endotracheal tubes (various models and sizes)
13-Device Common or usual name: Tracheal tubes
14-Device Classification Name: Tracheal tubes
15-Substantial Equivalency is claimed against the following device:
- For oral/nasal, cuffed and uncuffed: K892432 .
- . For nasal only, cuffed: K931164
- For oral only, cuffed: K931163 .
- For nasal only, uncuffed: K931165 .
- For oral only, uncuffed: K931166 .
11-Description of the Device:
Tiger Medical Products Ltd's Endotracheal tube is available in 90 different variants distributed among 6 main configurations and different sizes, as detailed below. It is marketed as sterile, single use, for airway management.
It consists of a clear tracheal tube with radiopaque blue stripe running its entire length, and it is graduated with multiple centimeter markings to allow easy detemination of intubated length, and is terminated with a 15mm standard connector.
It conforms to ISO 5261: 1999 and ASTM F1242: 1996 with one minor exception in the tube marking.
The six categories (or confiqurations) are listed below:
- (a) CATEGORY 1: uncuffed, oral/nasal:
It is provided as uncuffed, murphy, oral/nasal, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes
(b) CATEGORY 2: uncuffed, nasal only:
It is provided as uncuffed, murphy, preformed nasal- 2 eyes, and in 0.5mm ID increments from sizes 2.0 to 10.0 inclusive, totalling 17 sizes
Page 9
{1}------------------------------------------------
-
(c) CATEGORY 3: uncuffed, oral only:
It is provided as uncuffed, murphy, preformed oral- 2 eyes, and it is provided as anones from sizes 2.0 to 10.0 inclusive, totalling 17 sizes -
(d) CATEGORY 4: cuffed, oral/nasal:
lt is provided as cuffed, murphy, oral/nasal, and in 0.5mm ID it is provided as sizes 4.0 to 10.0 inclusive, totalling 13 sizes -
(e) CATEGORY 5: cuffed, nasal only:
It is provided as cuffed, murphy, preformed nasal, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes -
(f) CATEGORY 6: cuffed, oral only:
lt is provided as cuffed, murphy, preformed oral, and in 0.5mm ID increments from sizes 4.0 to 10.0 inclusive, totalling 13 sizes
12-Intended use of the device: (refer to FDA form attached)
The intended use for all the product variants is grouped into three different sections:
(a) CATEGORY 1 (uncuffed, oral/nasal) and CATEGORY 4 (cuffed, oral /nasal): The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management.
(b) CATEGORY 2 (uncuffed, nasal only) and CATEGORY 5 (cuffed, nasal only): The intended use of this device is to be intubated into a patient's trachea via the nose f no intentionally management, specifically for use in surgical procedures involving the head, neck and face.
(c) CATEGORY 3 (uncuffed, oral only) and CATEGORY 6 (cuffed, oral only): The intended use of this device is to be intubated into a patient's trachea via the mouth for airway management, specifically for use in surgical procedures involving the head, neck and face.
13-Safety and Effectiveness of the device:
This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.
PAGE 10
{2}------------------------------------------------
| FDA file reference number: | 510k # |
|---|---|
| Uncuffed, oral/Nasal | K892432 |
| Uncuffed, nasal only | K931165 |
| Uncuffed, oral only | K931166 |
| Cuffed, oral/Nasal | K892432 |
| Cuffed, nasal only | K931164 |
| Cuffed, oral only | K931163 |
| TECHNOLOGICALCHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Similar |
| Sterility | Similar |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Similar |
| Energy used and/or delivered | N/A |
| Compatibility with environment andother devices | N/A |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | N/A |
| Thermal safety | N/A |
| Radiation safety | N/A |
.
Refer to the submission for more details concerning dimensional and technological
.complessions for all 6 categories, as well as corresponding engineering drawings and samples supplied.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2005
Tiger Medical Products, Limited C/O Mr. Jay Mansour Tiger Regulatory 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K041311
Trade/Device Name: Tiger Endotracheal Tubes Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: February 28, 2005 Received: March 4, 2005
Dear Mr. Mansour:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your end 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, of to use, 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 approvisions 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.
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 (1 vir 1), it wean 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.
{4}------------------------------------------------
Page 2 - Mr. Mansour
Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast that FDA has made a determination that your device complies with other requirements Incan that I DA mas made a statutes and regulations administered by other Federal agencies.
You must comply with all the Act's requirements, including, but not limited to: registration I ou inust comply with an are reseling (21 CFR Part 801); good manufacturing practice and if in the (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation control provisions (Sections 531-542 of the Act); apprication, the noon one fetter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence m 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), If you desire specific at not to to pliance at (240) 276-0120. 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 from the Inter 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/industry/support/index.html.
Sincerely yours,
Cieu Seliom byr
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Tiger Endotracheal Tubes
Indications For Use:
The indication for use for all the product variants is grouped into three different sections:
(a) Uncuffed, oral/nasal and Cuffed, oral /nasal:
(a) Unculted, orainasal and Culled, oral maoun.
The intended use of this device is to be intubated into a patient's trachea via the nose or mouth for airway management.
(b) Uncuffed, nasal only and Cuffed, nasal only:
(b) Unculted, nasal only and Culled, hasar only.
The intended use of this device is to be intubated into involving the head, neck a The intended use of this device is to be intubation into a parchite interest involving the head, neck and face.
(c) Uncuffed, oral only and Cuffed, oral only:
Infaction Control. Dent
310(k) Number.
(c) Unculted, oral only and Culled, orar only.
The intended use of this device is to be intubated into a patients involving the hood, nock an The intended use of this device is to be intubated into a patients involving the head, neck and face.
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)
. 16 mon Gign-Oif) ് സമീന വ്യൂസ-Ciri, General Hospital,
Page 1 of
PAGE-12
§ 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).