(104 days)
The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg).
The EasyFit SilkGel Nasal Mask is a molded plastic mask, including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy. It consists of a mask cushion, mask body, forehead cushion, rough adjustment component, fine adjustment component, headgear clips, pressure measurement connection, tube anchoring strap, rotating sleeve, elbow, and retaining ring. The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.
The provided text describes a 510(k) summary for the EasyFit SilkGel Nasal Mask, which is a medical device intended for CPAP and Bi-level Positive Pressure therapy. The summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for the new device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: The document only generally states that "All tests were verified to meet acceptance criteria" without listing specific criteria or their performance metrics.
- Sample sized used for the test set and the data provenance: No details on sample sizes or data provenance for any tests are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not a study involving human experts establishing ground truth for a diagnostic AI device.
- Adjudication method for the test set: Not applicable.
- 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 as this is not an AI diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as this is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable as this is not an AI algorithm.
Based on the provided text, here is what can be extracted regarding the "acceptance criteria" and "study":
1. Acceptance Criteria and Device Performance (General Statement):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Safety (Biocompatibility) | Verified to meet acceptance criteria. |
| Performance Equivalence (Bench Testing) | Verified to meet acceptance criteria. |
| Overall Safety and Effectiveness | Concluded to be substantially equivalent to the legally marketed predicate device, and safe and effective for its intended use, performing as well as the predicate device. |
Note: Specific numerical criteria or performance metrics are not provided in the document.
2. Sample size used for the test set and data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The testing itself (biocompatibility and bench testing) would typically be conducted by the manufacturer (Weinmann - Gerate fur Medizin GmbH + Co. KG, Germany).
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 as the document describes a 510(k) submission for a physical medical device (nasal mask) and not a study establishing ground truth for a diagnostic AI system or a similar type of analysis.
4. Adjudication method for the test set:
- Not applicable for this type of device submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done, as this is not an AI diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI algorithm.
7. The type of ground truth used:
- Not applicable in the context of ground truth for diagnostic accuracy. The "ground truth" here would relate to established scientific standards for biocompatibility and engineering performance standards for a medical device.
8. The sample size for the training set:
- Not applicable as this is not an AI algorithm or machine learning device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI algorithm or machine learning device.
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11. 510(k) Summary
JUL 1 2 2011
EasyFit SilkGel Nasal Mask
June 07, 2011
Submitter Information:
Weinmann - Gerate fur Medizin GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg Germany
| Submitter's Name: | Dr. Ralf Egenolf |
|---|---|
| Phone: | 011 49 40 54 70 2 - 370 |
| Fax: | 011 49 40 54 70 2 - 468 |
Device Name:
| Proprietary name: | EasyFit SilkGel Nasal Mask |
|---|---|
| Common Name: | Nasal Mask |
| Classification Name: | Accessory to non-continuous ventilator |
Device Classification:
21 CFR 868.5905, Class II, Product Code BZD
Predicate Device Equivalence:
Substantial equivalence is claimed to SOYALA GEL vented, cleared for commercial distribution per K081014.
Device Description:
The EasyFit SilkGel Nasal Mask is a molded plastic mask, including an exhalation system, for the delivery of CPAP or Bi-level Positive Pressure therapy.
It consists of a mask cushion, mask body, forehead cushion, rough adjustment component, fine adjustment component, headgear clips, pressure measurement connection, tube anchoring strap, rotating sleeve, elbow, and retaining ring.
The mask provides a swivel and securely attached elbow connection for simple and secure handling of the tubing between the mask and the therapy device.
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Intended Use:
The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg).
Comparison of Technological Characteristics
The EasyFit SilkGel Nasal Mask has the same technological characteristics as the predicate device.
The modified device has the following similarities to the previously cleared predicate device:
- Same intended use .
- Same operating principle .
- Same fundamental scientific technology .
- Same mask design .
Some materials and mechanical details are changed in the modified device. Safety and effectiveness are not affected by these changes.
Summary of Device Testing:
Biocompatibility testing was performed to verify the equivalent safety of the materials that are used. Bench testing was performed to verify equivalent performance. All tests were verified to meet acceptance criteria.
Conclusion:
Based on the above, we concluded that the EasyFit SilkGel Nasal Mask is substantially equivalent to the legally marketed predicate device and is safe and effective for its intended use, and performs as well as the predicate device.
End of section
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle or bird-like symbol with three curved lines forming its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Ralf Egenolf Head of Quality Management and Regulatory Affairs Weinmann Gerate Fur Medizin GmbH + Company KG Kronsaalsweg 40 Hamburg, Germany 22525
JUL 12 2011
Re: K110884
Trade/Device Name: EasyFit SilkGel Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 9, 2011 Received: June 13, 2011
Dear Dr. Egenolf:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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- Dr. Egenoplf
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A.
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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6. Indications for Use
510(k) Number (if known):
Device Name: EasyFit SilkGel Nasal Mask
Indications for Use:
The nasal mask is intended for prescription use to be used during nasal CPAP or Bi-level Positive Pressure therapy for adult patients (>30 kg).
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division an-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of _1
510(k) Number: K/
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).