(256 days)
To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.
The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.
The provided text is a 510(k) summary for a medical device (Percutaneous Dilation Tracheostomy Kit) seeking market clearance. In 510(k) submissions, the primary "acceptance criterion" is often substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through controlled studies with explicit acceptance criteria.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technical characteristics and indications for use, and sometimes through performance testing if the device introduces new technology or significantly different characteristics.
Based on the provided text, here's an analysis structured around your request:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly list quantitative "acceptance criteria" in the way one might expect for an AI/algorithm-based device (e.g., AUC > X, sensitivity > Y). Instead, the core acceptance criterion is substantial equivalence to predicate devices. The "reported device performance" is essentially the claim of having similar technical characteristics and safety/effectiveness as the predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence: The device is as safe and effective as legally marketed predicate devices. (Primary acceptance criterion for 510(k)) | "The testing performed and comparison to predicate devices demonstrate that the proposed device is safe and effective and substantially equivalent to the predicate devices." (Conclusion statement) |
| Technical Characteristics Equivalence: Maintain similar technical characteristics to predicate. | "Percutaneous Dilation Tracheostomy Kit with Serial Dilators/Introducers for 7, 8 and 9mm tubes only, without Tracheostomy Tube (REF 100/566/000) has the same technical characteristics as the currently marketed Rusch "PercuQuick Set" Percutaneous Tracheostomy Kit." K011210." Additionally, specific components are equated to other predicates. |
| Indications for Use Equivalence: Same intended purpose as predicate devices. | "To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management." (Identical to predicate's stated use, though not explicitly stated as 'identical' in the text, it's implied by the substantial equivalence claim). |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of an algorithm or diagnostic device. For this type of physical medical device, "testing" likely refers to bench testing, biocompatibility testing, material testing, and potentially limited cadaver or animal testing (though not explicitly detailed here). There is no mention of a "test set" in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the provided 510(k) summary. The submission focuses on product design, materials, and comparison to predicates, not on establishing ground truth for a diagnostic algorithm.
4. Adjudication method for the test set
Not applicable, as no test set in the diagnostic sense is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a physical tracheostomy kit, not an AI or imaging-related device that would be subject to such a study design.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is a physical kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, the "ground truth" to be demonstrated is largely based on the established safety and performance of its predicate devices and the physical characteristics/materials meeting design specifications.
8. The sample size for the training set
Not applicable, as there is no "training set" for an algorithm described.
9. How the ground truth for the training set was established
Not applicable.
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510k SUMMARY
MAR 2 1 2003
COMPANY INFORMATION:
Portex Ltd, Hythe,Kent. England CT21 6DB 1022212
Contact: Steve Ogilvie Regulatory and Scientific Affairs Director
PREPARATION DATE OF SUMMARY:
10th February 2003
TRADE NAME
Percutaneous Dilation Tracheostomy Kit with Serial Dilators/Introducers for 7, 8 and 9mm tubes only, without Tracheostomy Tube (REF 100/566/000)
COMMON NAME
Percutaneous Tracheostomy Kit
PRODUCT CLASS/CLASSIFICATION
Class II 73 JOH, 21 CFR 868.5800
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510k SUMMARY
PREDICATE DEVICES
Main Product Predicates:
- Rusch "PercuQuick Set" Percutaneous Tracheostomy Kit." Legally marketed in ● the USA under K011210
- Portex "Per-Fit Percutaneous Tracheostomy Kit" Legally marketed in the USA . under K936133
| Kit Component/Element Predicates: | |||
|---|---|---|---|
| -- | ----------------------------------- | -- | -- |
| Component/Element | Predicate |
|---|---|
| Hydrophilic coating forSerial Dilators/Introducers | Mallinckrodt “Finch” and “Copperhead” PercutaneousTransluminal Angioplasty Catheters already marketed inthe USA under K983830 |
| Scalpel | Maersk/Paragon Single Use Scalpel already sold intoUSA under device listing R027050. |
| Syringe | ASIK ‘ONCE’ Syringe already marketed in the USAunder K852444 |
| Guidewire materials | TFX guidewire already marketed in the USA underK963320 |
| 14G Needle and Cannulamaterials | Wallace IV Cannula already marketed in the USA underK932946 |
| 14Fr Pre-dilator materials | Base Polymer - Portex Adjustable Flange Tracheostomytube already marketed in the USA under K962175.Colourant - Portex Y-Cann already marketed in the USAunder K032047 |
DESCRIPTION:
The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube.
The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.
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510k SUMMARY
INDICATIONS FOR USE:
"To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management."
TECHNICAL CHARACTERISTICS:
Percutaneous Dilation Tracheostomy Kit with Serial Dilators/Introducers for 7, 8 and 9mm tubes only, without Tracheostomy Tube (REF 100/566/000) has the same technical characteristics as the currently marketed Rusch "PercuQuick Set" Percutaneous Tracheostomy Kit." K011210. Where necessary, the Portex "Per-Fit Percutaneous Tracheostomy Kit'' K936133 is used as a predicate for specific features and/or characteristics.
CONCLUSION
The testing performed and comparison to predicate devices demonstrate that the proposed device is safe and effective and substantially equivalent to the predicate devices.
For Portex Ltd.
Suara
Steve Ogilvie
Regulatory and Scientific Affairs Director
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are abstract and flowing, creating a sense of unity and connection. Encircling the profiles is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
MAR 21 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Ogilvie Regulatory and Science Affairs Director Portex. Limited Military Road Hythe. Kent United Kingdom CT21 6DB
Re: K022212
Trade/Device Name: Percutaneous Dilation Tracheostomy Kit (Serial Dilators) Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: February 13, 2003 Received: February 24, 2003
Dear Mr. Ogilvie:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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 - Mr. Steve Ogilvie
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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 the labeling regulation, please contact the Office of Compliance at (301) 594- . . Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Susan Runner, DDS, MA
Interim 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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510(k) Number (if known): K022212
Device Name: Portex Percutaneous Dilatiational Tracheostomy Kit
Indications for Use:
To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.
Approved: su 12/feb/03
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sai C. Hino 3/28/2003
510(k) Number: K022212
§ 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.