(72 days)
The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting.
Not Found
The provided FDA 510(k) clearance letter for the Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria.
This document is a clearance letter, which means the FDA has determined that the device is "substantially equivalent" to a legally marketed predicate device. This determination is based on a review of the company's 510(k) submission, which would have included information comparing the new device to the predicate device. However, the clearance letter itself only states the outcome of that review and the indications for use.
Therefore, I cannot provide the specific details you've requested. Here's why and what's typically missing:
- Acceptance Criteria and Reported Device Performance: This letter summarizes the regulatory decision, not the performance data itself.
- Sample Size and Data Provenance: This information would be in the detailed submission, not the clearance letter.
- Number of Experts and Qualifications: This applies to studies, which are not detailed here.
- Adjudication Method: Again, this is study-specific information.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a type of study often done for AI/CAD devices, but not relevant for a physical medical device like a mask, and certainly not detailed in this clearance letter.
- Standalone Performance: This device is a physical mask for ventilation, not an algorithm.
- Type of Ground Truth: This refers to the reference standard in a diagnostic study, which is not applicable here.
- Sample Size for Training Set: Not applicable for this type of device or documentation.
- Ground Truth for Training Set: Not applicable for this type of device or documentation.
To obtain the kind of detailed information you're asking for, you would typically need to review the full 510(k) submission, which is significantly more extensive than the clearance letter. These submissions often include detailed test reports, performance data, and comparisons to predicate devices.
FDA 510(k) Clearance Letter - Hans Rudolph 7500 Series NIV Masks
Page 1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
MAY - 2 2003
Mr. Kevin Rudolph
Vice President
Hans Rudolph, Incorporated
7200 Wyandotte
Kansas City, Missouri 64114
Re: K030515
Trade/Device Name: Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks
Regulation Number: 21 CFR 868.5895
Regulation Name: Continuous Ventilator
Regulatory Class: II
Product Code: 73 CBK
Dated: January 13, 2003
Received: February 19, 2003
Dear Mr. Rudolph:
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. Rudolph
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" (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
Page 3
Page 1 of 1
INDICATIONS FOR USE STATEMENT
510(k) Number: K030515
Device Name: Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks
Indications For Use:
The Hans Rudolph 7500 Series Reusable Oro-Nasal NIV Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. The mask is multi-patient reusable. It is intended for use on adult patients above 30 kilograms weight, who are appropriate candidates for noninvasive ventilation, in the home, hospital, or other clinical setting.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K030515
Prescription Use ✓
(Per 21 CFR 801.109)
OR Over-The-Counter Use ___
(Optional Format 1-2-96)
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).