(29 days)
The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
The Provox® FreeHands system consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position".
The provided text describes the "Provox® FreeHands HME™" device and references a clinical test. However, it does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. The document is primarily a 510(k) summary, focusing on substantial equivalence to predicate devices rather than a full performance study.
Based on the available information, here's what can be extracted and what is missing:
The document mentions a "clinical test" and states that "Test results support the conclusion that the actual device performance satisfies the design intent." However, the specifics of this "design intent" (i.e., the acceptance criteria) are not detailed with numerical thresholds.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The general statement is that "Test results support the conclusion that the actual device performance satisfies the design intent."
- Reported Device Performance: The document states that a comparison was made between the Provox® FreeHands HME™, Provox® HME Cassette, and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap. The implication is that the Provox® FreeHands HME™ performed acceptably compared to these predicates, but specific performance metrics (e.g., heat/moisture retention percentages, speech clearness, breathability) are not provided.
| Acceptance Criteria (Not explicitly stated) | Reported Device Performance (General Statement) |
|---|---|
| Specific quantitative thresholds | "Test results support the conclusion that the actual device performance satisfies the design intent." |
| Specific comparative metrics to predicates | Device performance was compared to Provox® HME Cassette and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: The clinical test was performed by the Netherlands Cancer Institute. It's described as a "clinical test," implying prospective collection, but not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Not specified.
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 device is a physical medical device (HME with speech valve), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to "human readers improving with AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a physical HME, not an algorithm. This question is not applicable.
7. The type of ground truth used
- Given it's a physical HME device, the "ground truth" would likely be objective measurements of HME performance (e.g., heat/moisture exchange efficiency), patient comfort, ease of speech, and potentially clinical outcomes related to respiratory health. However, the exact type of ground truth or specific metrics used in the "clinical test" are not detailed in the provided text.
8. The sample size for the training set
- The document describes a clinical test for evaluation, not a training/test set split as commonly found in machine learning/AI studies. Therefore, a "training set" in that context is not applicable.
9. How the ground truth for the training set was established
- As above, a "training set" is not mentioned in the context of this device evaluation.
In summary, while a clinical test was conducted by the Netherlands Cancer Institute, the provided 510(k) summary is very high-level and lacks the detailed performance metrics, sample sizes, expert qualifications, and adjudication methods that would constitute a comprehensive description of acceptance criteria and the study proving it.
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188
MEDICAL
JUL 3 0 2002
Premarket Notification 510(k) Provox® FreeHands HME™
Page 1 of 3
| 5.4 510(k) Summary of Safety and Effectiveness |
|---|
| ------------------------------------------------ |
| Date | Thursday, June 27, 2002 |
|---|---|
| 510(k) Number | K022125 (To be assigned) |
| Submitter's Name | Atos Medical ABP O Box 183Kraftgatan 8SE-242 22 HörbySweden |
| Telephone: Int+46-415-198 00Fax: Int+46-415-198 98E-mail: info@atosmedical.com | |
| Contact Person | Eddy ÅbergDirector of Quality & Regulatory Affairs |
| Trade or Proprietary Name | Provox® FreeHands HMETM |
| Common or Usual Name | Heat and Moisture Exchanger with a Speech Valve |
| Device Classification Name | Tracheostomy Tube and Tube Cuff |
| Product Code | 73 JOH |
| Predicate Devices | Provox® HME Cassette510(k) Number : K014102Atos Medical AB, SwedenBlom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap510(k) Number: K821568Inhealth Technologies, USABivona™ Tracheostoma Valve II510(k) Number: K852272Bivona Medical Technologies, USA |
| Intended Use | The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and |
Org. nr.
556268-7607
Vat No. SE556268760701
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Image /page/1/Picture/2 description: This document describes the Provox FreeHands system, which consists of two functional units that work together. The first unit is a reusable speech valve unit with two independent valves, and the second unit is a disposable HMET cassette. The document explains that the speech valve unit allows hands-free tracheostoma occlusion for voice prosthesis users. It also describes the two valve positions, the "speaking position" and the "breathing position", and mentions that the clinical test was performed by the Netherlands Cancer Institute.
O Box 183 Kraftoaten 8 SE-242 22 Horbv Sweder
46 415 198 00 46 415 198 98 info@atosmedical co www.atosmedical.com 112878-17
5-14
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Premarket Notification 510(k) Provox® FreeHands HME™
Page 3 of 3
approved the study. A comparison was made between Provox® FreeHands HME™, Provox® HME Cassette and Blom-Singer Adjustable Tracheostoma Valve with HumidiFilter Cap.
Test results support the conclusion that the actual device performance satisfies the design intent.
Technological Characteristics
The proposed device is substantially equivalent to the legally marketed predicate devices in design, intended use and materials of manufacturer.
P O Box 183 Kraftgatan 8 SE-242 22 Horby Sweden
Phone +46 415 198 00 +45 415 198 98 Fax E-mail ınfo@atosmedical.com Web www.atosmedicai.com
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JUL 3 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Atos Medical, Inc. c/o Paul Dryden ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055
Re: K022125
Trade/Device Name: Provox FreeHands HME, Model 7710 Regulation Number: 21 CFR 874.3730 Regulation Name: Laryngeal Prosthesis (Taub Design) Regulatory Class: Class II Product Code: EWL Dated: June 27, 2002 Received: July 1, 2002
Dear Mr. Dryden:
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.
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.
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. Page 2 – Paul Dryden
: 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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MEDICA
Indications for Use 5.3
| Applicant: | Atos Medical AB, Sweden |
|---|---|
| 510(k) Number: | K022125 (To be assigned) |
| Device Name: | Provox® FreeHands HMETM |
Intended Use:
The Provox® FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.
PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
(Division Sign Off) Division of Ounthalmic Ear, Nos and Throat Devises
510(k) Number
P O Box 183 Kraftgatan 8 SE-242 22 Horby Sweden
or
Over-the-counter_
(Per 21 CFR 801.109)
+46 415 198 00 Phone +46 415 198 98 Fax E-mail info@atosmedical com www.atosmedical.com Web
Org. nr. 556268-7607 Val No SE556268760701 5-12
§ 874.3730 Laryngeal prosthesis (Taub design).
(a)
Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.(b)
Classification. Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.