(403 days)
Due to the current limitations of the provided document, I cannot identify the Predicate Device(s) K/DEN number. The text only mentions "Respironics Whisper Swivel II" without providing a K/DEN number.
Not Found
No
The device description and other sections do not mention any AI or ML capabilities. It is described as a passive mechanical component.
No.
The device is a passive exhalation outlet that provides a continuous leak path for exhaled air in a sleep apnea therapy device; it does not directly provide therapy itself but is an accessory to a therapeutic device.
No
The device is described as an "exhalation outlet" for sleep apnea therapy, providing a "continuous leak path for the patients exhaled air." Its function is mechanical (allowing air out) and connective (quick connection/disconnection), not to analyze or diagnose a medical condition.
No
The device description clearly states it is a "passive exhalation outlet" consisting of "2 parts" that are physically placed in a patient circuit. This describes a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Aero-Click ® is described as a passive exhalation outlet used in sleep apnea therapy. Its function is to manage exhaled air and facilitate connection/disconnection of the mask. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for sleep apnea therapy, not for diagnostic testing.
Therefore, the Aero-Click ® falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Exhalation outlet for use between masks without openings and air tube for sleep apnoea therapy equipment including quick connector/disconnector capabilities
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
The Aero-Click ® is a passive exhalation outlet which is placed in the patient circuit between the mask and the air tube of a sleep apnoea therapy device to provide a continuous leak path for the patients exhaled air. It is placed near the patient's face and allows quick connection/disconnection of the mask from the sleep apnoea therapy device.
The device consists of 2 parts which can be easily disconnected. It can be cleaned with dish-washing detergents. Cleaning requires disconnection of the device.
The device can be desinfected with Cidex ®.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home and Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Respironics Whisper Swivel II
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Non-Confidential Summary of Safety and Effectiveness
page 1 of 3 / August 16, 1999
| MAP
MEDIZINTECHNIK FÜR ARZT UND PATIENT
| Germany | |
|---|---|
| Manufacturer | MAP Medizintechnik für Arzt und Patient GmbH & Co. KG |
| Fraunhoferstrasse 16 | |
| D-82152 Martinsried | |
| Germany | |
| Official Contact | Torsten Schlichtholz, Manager, Quality Management |
| Proprietary or Trade Name | Aero-Click ® |
| Common/Usual Name | Passive Exhalation Outlet |
| Classification Name | Non-Continuous Ventilator |
| Device | Aero-Click ® |
| Predicate device | Respironics Whisper Swivel II |
| Device Description | The Aero-Click ® is a passive exhalation outlet which is placed in the patient circuit between the mask and the air tube of a sleep apnoea therapy device to provide a continuous leak path for the patients exhaled air. It is placed near the patient's face and allows quick connection/disconnection of the mask from the sleep apnoea therapy device. |
| The device consists of 2 parts which can be easily disconnected. It can be cleaned with dish-washing detergents. Cleaning requires disconnection of the device. | |
| The device can be desinfected with Cidex ®. | |
| Intended Use | |
| Indicated Use | Exhalation outlet for use between masks without openings and air tube of sleep apnoea therapy equipment including quick connector/disconnector capabilities |
| Targeted Population | Adults |
| Environment of Use | Home and Hospital |
| Equipment | Sleep Apnoea Therapy Equipment |
1
Non-Confidential Summary of Safety and Effectiveness (continued)
page 2 of 3 / August 16, 1999
| Comparison with Predicate Devices | ||
|---|---|---|
| Attribute | Aero-Click ® | Respironics Whisper |
| Swivel II | ||
| Use | ||
| Intended Use: | ||
| Breathing circuit passive exhalation port | Yes | Yes |
| Intended Equipment: | ||
| CPAP or bi-Level systems | Yes | Yes |
| Intended environment: | ||
| Home and Hospital | Yes | Yes |
| Connector/disconnector capabilities | Yes | No |
| Design | ||
| Provides continuous flow leak path in circuit | Yes | Yes |
| Placed close to Patients face | Yes | Yes |
| Made to be cleaned | Yes | Yes |
| Provided non-sterile | Yes | Yes |
| Reusable | Yes | Yes |
| Materials | ||
| Polycarbonate | ||
| Stainless steel | Yes | |
| Yes | Yes | |
| No | ||
| Performance Standards/Specifications | ||
| Meets design requirements after cleaning | Yes | Yes |
.
2
Non-Confidential Summary of Safety and Effectiveness (continued)
page 3 of 3 / August 16, 1999
Differences between other legally marketed devices:
The differences between the Whisper Swive! II and the Aero-Click ® are as follows: Use of a stainless steel spring to assure safe connection of both parts of the device instead of polycarbonate.
Flow at 100% relative humidity is higher in Aero-Click ® compared to Whisper Swivel II. The 2 parts of the device can be quickly connected/disconnected without removing the mask
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2000
Mr. Torsten Schlichtholz MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH FraunhoferstraBe 16 D-82152 Martinsried GERMANY
- Re: K993094 Aero-Click® Requlatory Class: II (two) Product Code: 73 BZD Dated: September 5, 2000 September 11, 2000 Received:
Dear Mr. Schlichtholz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Torsten Schlichtholz
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594–4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
James E. Dillard III
Director
Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use 4.
The following is provided persuant to the Notice of February 6, 1996, regarding Indications for Use
| 510(k) Number (if known):. | To be assigned |
|---|---|
| Device Name: | Aero-Click ® |
| Intended Use: | Exhalation outlet for use between masks without |
| openings and air tube for sleep apnoea therapy including | |
| quick connector/disconnector | |
| Target Population: | Adults |
| Invironment of Use: | Home and Hospital |
| Equipment for Use: | Sleep Apnoea Therapy Equipment, CPAP and bi-level |
| Reusable: | Reusable, Multi Use |
| May be disassembled and cleaned | |
| Provided non- sterile |
Bmu
Division Sign Off
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K993094