(54 days)
The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer and components of these kits that allow for tracheal access for airway management for use in adults only.
The Portex "Ultra Perc" single use Percutaneous Dilation Tracheostomy Kits allow the percutaneous insertion of the Police Sublic Fere "Single discriptions of the stage) circumferencial dilatational Seldinger guidewire technique. Kits are supplied with a Portex Blue Line Ultra Tracheostomy Tube and introducer. The kits are intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel. A minimum of 2 operators are required - one to maintain the patient's airway, anaesthesia, breathing and circulation, and the other to perform the procedure. The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra The Forex Forealizer, are available in sizes 7.0, 8.0 and 9.0mm only.
The provided text is a 510(k) summary for a medical device (Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit). It aims to demonstrate substantial equivalence to previously marketed predicate devices, not primarily to prove device performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, for many of the requested points, the information is not present in the provided document. This is typical for a 510(k) submission that relies on substantial equivalence rather than new clinical effectiveness trials.
Here's an analysis based on the provided text, addressing each point where possible:
Acceptance Criteria and Device Performance Study for Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit
The provided document does not contain explicit acceptance criteria in the typical sense of numerical thresholds for a new clinical study. Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by 510(k) for Substantial Equivalence) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Safety: Device is as safe as predicate devices. | The device is intended for use in environments like an Intensive Care Unit or operating room with trained personnel (minimum 2 operators). No specific safety metrics or quantified performance against safety criteria are provided, as substantial equivalence to predicate devices (already marketed and presumed safe) is asserted. |
| Effectiveness: Device is as effective as predicate devices for its intended use. | Intended Use: To create a percutaneous dilatational tracheostomy using guidewire dilators and components of the kit for tracheal access for airway management in adults. This is equivalent to the predicate devices. |
| Technological Characteristics: Similar in design, materials, and operating principle, or any differences do not raise new questions of safety or effectiveness. | The proposed device is stated to be equivalent to predicate devices in "all aspects except for the following: Tracheostomy tube Introducer." The curvature and materials of the Introducer will be compared with the Single Stage Dilator of Predicate 2 and the obturator of Predicate 3. The handle will be compared to the Single Stage Dilator of Predicate 2 and the Obturator/Introducer of Predicate 4. These comparisons are implied to demonstrate equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Performance data for the proposed device is shown in section 8.0 Performance. Clinical data is provided in Appendix 2." However, Section 8.0 and Appendix 2 are not provided in the excerpt. Therefore, the sample size or provenance of any direct test data for the proposed device is unknown from the given text.
The primary "evidence" for this 510(k) is based on the equivalence to predicate devices which have established clinical use. This is not a study that uses a "test set" in the traditional sense of a clinical trial for a novel device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert-established ground truth for a test set. The focus is on demonstrating substantial equivalence to predicate devices, which are already in clinical practice.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this 510(k) submission.
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
Not applicable. This device is a medical kit for a surgical procedure, not a diagnostic AI device. Therefore, an MRMC study and effects on human readers are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device kit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in a 510(k) submission based on substantial equivalence is the safety and effectiveness profile of the predicate devices as established by their prior marketing and clinical use. No new ground truth needed to be established for the proposed device, beyond demonstrating its similarity to these predicates.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Smiths Medical: Portex Percutaneous Dilation Tracheostomy kit with Secial Dilators or Single Stage Dilators, Blue Line Ultra Tracheostomy Tube and Introducer 510(K) Notification
KD41348
JUL 1 3 2004 SECTION 5.0 : 510K SUMMARY
DATE SUBMITTED: 6th May 2004
| SUBMITTER: | Smiths Medical |
|---|---|
| Hythe | |
| Kent | |
| England, CT21 6JL |
CONTACT PERSON:
Mr Barry Smith Regulatory Affairs Manager Smiths Medical, Hythe, Kent, England. CT21 5BN Phone 00 44 (0) 1303 26055 1 Fax 00 44 (0)1303 264679 e-mail: barry.smith(@smiths-medical.com
DEVICE NAME:
Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer.
COMMON NAME AND CLASSIFICATION:
Percutaneous Dilation Tracheostomy kit with Serial Dilators. Class II BTO, 21 CFR 868.5800
PREDICATE DEVICES:
- Portex Ltd: Portex Perculaneous Dilation Trachcostomy Kit with Scrial Dilators. already marketed in the 1. USA under K022212
- Portex Ltd: Portex Perculancous Dilation Trachcostomy Kit with Single Stage Dilator already marketed in 2. the USA under K040014
- Portex Ltd: Blue Line Ultra Tracheostomy Tube kits, already marketed in the USA under K030381 ﻢ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
- Portex Inc. Perculaneous Dilatory tracheostomy Kit with Speciality tracheostomy Tube (Perfit) already 4. marketed in the USA under K980466
- Rusch Percuquick set for percutaneous dilation tracheostomy already marketed in the USA under K011210 5.
- Shiley Low Pressure Cuffed tracheostomy tube already marketed in the USA under K8802+7 ().
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Smiths Medical: Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilators, Blue Line Ultra Trachcostomy Tube and Introducer 510(K) Notification
SECTION 5.0 : 510K SUMMARY
DEVICE DESCRIPTION:
The Portex "Ultra Perc" single use Percutancous Dilation Trachcostomy Kits allow the perculancous insertion of I he Police Sublic Fere "Single discriptions of the stage) circumferencial dilatational Seldinger guidewire technique.
Kits are supplied with a Portex Blue Line Ultra Tracheostomy Tube and introducer.
The kits are intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel. A minimum of 2 operators are required - one to maintain the patient's airway, anaesthesia, breathing and circulation, and the other to perform the procedure.
The Portex Perculaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra The Forex Forealizer, are available in sizes 7.0, 8.0 and 9.0mm only.
INTENDED USE:
The Portex "Ultra Perc" Perculaneous Dilation Trachcostomy kit with Serial Dilators or Single Stage Dilator. The Line Ultra Tracheostomy Tube and Introducer are indicated to create a percutaneous difiational tracheostomy using guidewire dilators and components of this kit that allow for tracheal access for airway management.
TECHNOLOGICAL CHARICTERISTICS OF PROPOSED VERSUS PREDICATE DEVICES:
- The proposed device is equivalent to Predicate devices 1 & 2- Portex Ltd: Portex Percutaneous Dilation . Tracheostomy Kits already marketed in the USA under K022212 and K040014 and Predicate 3 - Portex Ltd. I racheostomy Tube kits already marketed in the USA under K03038 lin all aspects except for the following:
- Tracheostomy tube Introducer. The proposed device has a Tracheostomy tube Introducer that o allows for the placement of the Blue Line Ultra Tracheostomy tube into the patients trachea. The curvature and materials of the Introducer will be compared with the Single Stage Dilator of Predicate 2 and the obturator of Predicate 3. The handle will be compared to he Single Stage Dilator of Predicate 2 and the Obturator/Introducer of Predicate 4
PERFORMANCE / CLINICAL DATA:
Performance data for the proposed device is shown in section 8.0 Performance. Clinical data is provided in Appendix 2
CONCLUSION:
Comparison of the proposed device to the predicate devices supports the conclusion that the proposed device is substantially equivalent in safety and effectiveness in its intended use to existing legally marketed devices.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2004
Mr. Barry Smith Regulatory Affairs Manager Smiths Medical, International Limited Military Road Hythe, Kent, CT21 5BN ENGLAND
Re: K041348
Trade/Device Name: Portex "Ultraperc" Percutaneous Dilation Tracheostomy Kit Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: JOH Dated: May 6, 2004 Received: May 20, 2004
Dear Mr. Smith:
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.
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 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. Smith
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); 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.
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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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 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,
Clus
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
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Smiths Medical : Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single al : Fortex Ferentaneous Ultra Tracheostomy Tube and Introducer 510(K) Notification
SECTION 4.0: STATEMENT OF INDICATIONS FOR USE
Document 1
DEVICE NAME:
Portex "Ultraperc" Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue Line Ultra Tracheostomy Tube and Introducer.
INDICATIONS OF USE:
The Portex Percutaneous Dilation Tracheostomy kit with Serial Dilators or Single Stage Dilator, Blue The Forex Ferentaneous Dhatton Tracheostenly mindicated to create a percuraneous dillational Lifte Unia Tractievslonly Tube and introducer and components of these kits that allow for tracheal access for airway management for use in adults only.
Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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)
Aun Syberot
(Division Sign-Division of Anesthesiology, General Hospital, Infection Control, De
510(k) Number
§ 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.