(590 days)
The Scalar, Scalar Plus, Vector, and Vector Plus devices are for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.
The Scalar, Scalar Plus, Vector Plus devices provide continuous positive airway pressure. The Scalar Plus and Vector Plus devices provide humidification of the air delivered to the patient.
Hoffrichter SCALAR and VECTOR CPAP devices provide mono-level CPAP treatment levels over the clinician settable range of 3 to 18 cmH2O.
All devices are constructed on a common platform, including case, mechanical and pneumatic components, operator panel, and electronic control system. A 2 x 16 character display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for time/date, ramp and other functions.
VECTOR's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC), whereas SCALAR is set to the region (115 or 230 VAC) by rear panel switch.
Models with a Plus designation include integrated heated humidification. An adjustment dial permits the user to select the humidification level. Moisture contacting materials in the breathing circuit meet biocompatibility requirements.
Treatment pressure is measured as close as possible to the patient mask by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit.
Hoffrichter CPAP devices have a user selectable ramp function, which starts with a reduced pressure and slowly increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time from 0 to 60 minutes. A mask test may be initiated at the full treatment pressure before the ramp begins to check for mask leaks.
Accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified.
A serially connected remote control device, the MULTI 20, supplied for clinician use during patient tests, emulates operator panel functions.
Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
The provided document describes the Hoffrichter Vector, Vector Plus, Scalar, and Scalar Plus CPAP devices. Based on the submission, here's a breakdown of the acceptance criteria and the study information:
Description of the Study and Acceptance Criteria
The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a previously legally marketed device (the predicate device). This means the study's primary goal is to show that the new device is as safe and effective as the predicate device. For CPAP devices, this typically involves demonstrating that the device can deliver the intended therapy (continuous positive airway pressure) within specified ranges and that it meets relevant safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table with specific numerical acceptance criteria for pressure accuracy or other performance metrics, nor does it report precise measured values for the Hoffrichter CPAP devices. Instead, the performance is described in comparison to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Compliance with applicable medical device standards | Passed all tests for Electrical Safety, Electromagnetic Compatibility, Heated Humidifiers, Shock and Vibration, and Environmental Temperature and Humidity. |
| Pressure Delivery: Provide mono-level CPAP treatment. | Delivers CPAP treatment levels over a clinician settable range of 3 to 18 cmH2O. Improved pressure control and accuracy compared to the predicate device due to pressure measurement at the mask via an integrated measurement hose. |
| Humidification: (For Plus models) | Integrated heated humidification with an adjustment dial for the user to select the humidification level. Motion contacting materials meet biocompatibility requirements. |
| Ramp Function: User-selectable ramp. | User can adjust ramp time from 0 to 60 minutes. |
| Dynamic and Static Pressure Performance: | Met or exceeded the performance specifications of the predicate device (Fischer and Paykel HC200 Nasal CPAP with Heated Humidifier). The Hoffrichter CPAP devices employ a more advanced pressure measurement system (at the mask) compared to the predicate device, which sets pressure by a manual blower speed adjustment, implying better performance in this aspect. |
| Software Validation: | Software across all platforms was verified to requirements and validated to meet intended use by pressure testing and event testing. |
| Biocompatibility: | Moisture contacting materials in the breathing circuit meet biocompatibility requirements. |
| Pneumatic Components: | Constructed on a common platform, including case, mechanical and pneumatic components, similar to the predicate device. |
| Intended Use Equivalence: | Indications for use are the same as the predicate device: treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg, not intended for use with ventilator-dependent patients (with available humidification for Plus models). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "the Hoffrichter CPAP devices" being tested, implying a representative number of units, but no specific count is given for the test set of devices or patients.
- Data Provenance: The document does not provide details on data provenance (e.g., country of origin, retrospective/prospective). Given the nature of a 510(k) for device performance testing, it's highly likely these were bench tests (non-clinical) and not conducted on human subjects as part of this submission. The address of the submitting company (Hoffrichter GmbH) is in Germany, suggesting the tests were conducted in Germany or Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable to this submission. The tests performed were non-clinical (bench testing) and compared the device's technical performance against established standards and the predicate device's specifications. There was no "ground truth" derived from expert consensus on medical conditions or interpretations.
4. Adjudication Method for the Test Set
This section is not applicable. Since no human interpretation or ground truth establishment based on expert consensus was involved, there was no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Clinical Tests Submitted: (2) (None)". The study focused on non-clinical (bench) testing of the device's technical specifications and safety.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is partially applicable in the sense that the device's performance was evaluated purely on its own technical capabilities (standalone) during bench testing. However, it's important to note that this is not an "algorithm only" in the context of AI/software performance. It's the performance of a physical medical device. The "software" component was verified and validated to requirements, which implies its performance characteristics were evaluated in a standalone manner.
7. The Type of Ground Truth Used
The "ground truth" or reference standards used for the non-clinical tests were:
- Applicable standards for medical devices: e.g., for Electrical Safety, Electromagnetic Compatibility, Heated Humidifiers, Shock and Vibration, Environmental Temperature and Humidity.
- Performance specifications of the predicate device: The Fischer and Paykel HC200 Nasal CPAP with Heated Humidifier (K973161).
8. The Sample Size for the Training Set
This section is not applicable. The device is a hardware medical device with embedded control software, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The software was verified and validated, meaning it met its specified requirements and functions as intended, but this doesn't involve a machine learning training phase.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
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JUL 2 3 2003
K014074: Hoffrichter Vector, Vector Plus, Scalar Plus: CPAP with Humidifier Option Page 1 of 3
510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | HOFFRICHTER GmbHMettenheimer Strasse 12/14D-19061 SchwerinGermanyTel.: +49-385-39925-0Fax: +49-385-39925-25E-mail: info@hoffrichter.de |
|---|---|---|---|
| Contact Person: | Norbert Küchemann | ||
| Position/Title: | Sales Manager | ||
| Date of Preparation: | May 19, 2003 | ||
| (2) | Trade Name: | VECTOR, VECTOR Plus;SCALAR, SCALAR Plus; Mono LevelCPAP devices with Humidifier Option | |
| Common/Classification Name: | VENTILATOR, CONTINUOUS,NON-LIFE-SUPPORTING;HUMIDIFIER, RESPIRATORY GAS(Humidification on Plus Models only) | ||
| Product Code(s): | MNS, 21 CFR §868.5895.BTT, 21 CFR §868.5450 | ||
| Class: | Class II | ||
| (3) | Predicate Device(s): | Fischer and Paykel HC200 Nasal CPAPwith Heated Humidifier (K973161) | |
| Reason for Submission: | New Device |
(4) Description of Device:
Hoffrichter SCALAR and VECTOR CPAP devices provide mono-level CPAP treatment levels over the clinician settable range of 3 to 18 cmH2O.
All devices are constructed on a common platform, including case, mechanical and pneumatic components, operator panel, and electronic control system. A 2 x 16 character display with keys on the operator panel provides the user with displayed information about the treatment level as well as access to menus for time/date, ramp and other functions.
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K014074: Hoffrichter Vector, Vector Plus, Scalar, Scalar Plus: CPAP with Humidifier Option Page 2 of 3
VECTOR's power supply automatically supply adapts to regional mains voltage (115 to 230 VAC), whereas SCALAR is set to the region (115 or 230 VAC) by rear panel switch.
Models with a Plus designation include integrated heated humidification. An adjustment dial permits the user to select the humidification level. Moisture contacting materials in the breathing circuit meet biocompatibility requirements.
Treatment pressure is measured as close as possible to the patient mask by means of a measuring tube integrated into the therapy tubing. This maximizes accuracy and control of pressure and minimizes losses due to the therapy delivery circuit.
Hoffrichter CPAP devices have a user selectable ramp function, which starts with a reduced pressure and slowly increases to the treatment pressure to make it more comfortable to fall asleep. The user can adjust the ramp time from 0 to 60 minutes. A mask test may be initiated at the full treatment pressure before the ramp begins to check for mask leaks.
Accessories include treatment tubing with integrated measurement tube and headgear. Commercially available masks and swivels are specified.
A serially connected remote control device, the MULTI 20, supplied for clinician use during patient tests, emulates operator panel functions.
Hoffrichter CPAP devices are prescription use devices, and are not intended for life supporting or life sustaining applications.
(5) Intended use:
Obstructive sleep apnea (OSA) is a condition caused by closing of the upper airway during sleep. The uvula and soft pallet collapse on the back wall of the upper airway, and when the tongue moves back, the airway is temporarily sealed, causing disruptions in normal respiration and sleep.
Continuous Positive Airway Pressure (CPAP) is an effective treatment for OSA. CPAP devices treat the condition by supplying a constant positive pressure to the airway, most commonly via the nasal passages, in order to prevent the collapse of the soft tissue of the uvula and soft palate during sleep.
Indications for Use:
The Scalar, Scalar Plus, Vector, and Vector Plus devices are for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.
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Page 3 of 3
The Scalar, Scalar Plus, Vector, Vector Plus devices provide continuous positive airway pressure. The Scalar Plus and Vector Plus devices provide humidification of the air delivered to the patient.
Indications for use are the same as the predicate device. Both devices state CPAP treatment for OSA in non ventilator-dependent adult patients, with available humidification.
Technological Characteristics: (6)
Hoffrichter CPAP devices employ the same technological The characteristics as the predicate device. Both employ a computer controlled blower system which is attached via tubing to a swivel and nasal mask to deliver a prescribed mono-level CPAP treatment to a patient over the range 3 to 18 cmH2O. Both employ a hotplate type design to heat a water reservoir to add humidification.
The predicate device sets pressure by a manual blower speed adjustment. The Hoffrichter CPAP devices employ pressure measurement at the mask via a measurement hose integrated into the breathing hose. This enables improved pressure control and accuracy by the Hoffrichter CPAP devices.
Non-Clinical Tests Submitted: (b) (1)
The Hoffrichter CPAP devices were tested in accordance with applicable standards for medical device Electrical Safety, Electromagnetic Compatibility, Heated Humidifiers, Shock and Vibration, and Environmental Temperature and Humidity. The CPAP devices passed all of the tests.
Static and dynamic pressure testing was performed in comparison with the predicate device. In all cases the Hoffrichter CPAP devices met or exceeded the performance specifications of the predicate device.
Software across all platforms was verified to requirements and validated to meet intended use by pressure testing and event testing.
Clinical Tests Submitted: (2) (None)
(3) Conclusions from Tests:
As described in (b)(1) above, all of the testing demonstrated that the Hoffrichter CPAP devices are as safe and effective as and perform as well or better than the predicate device, the Fisher and Pavkel HC200.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2003
Hoffrichter GmbH C/O Mr. Stephen H. Gorski Consultant Imagenix, Incorporated S65 W 35739 Piper Road Eagle, WI 53119
Re: K014074
Trade/Device Name: Hoffrichter Scalar, Scalar Plus, Vector, and Vector Plus CPAP Devices Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator Regulatory Class: II Product Code: BZD Dated: May 19, 2003 Received: May 22, 2003
Dear Mr. Gorski:
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 vour 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. Stephen H. Gorski
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 (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.
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 vours.
foffluhm
for,
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
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K014074 510(k) Number (if known):
Hoffrichter Vector, Vector Plus, Scalar, Scalar Plus: CPAP with Device Name: Humidifier Option
Indications for use:
The Scalar, Scalar Plus, Vector, and Vector Plus devices are for treatment of obstructive sleep apnea (OSA) in adult patients weighing at least 30 kg. These devices are not intended for use with ventilator-dependent patients.
The Scalar, Scalar Plus, Vector Plus devices provide continuous positive airway pressure. The Scalar Plus and Vector Plus devices provide humidification of the air delivered to the patient.
Caution: Federal law restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
foAWth
Anesthesiology, General Hospital.
510(k) Number: K014074
Prescription Use X (Per 21 CFR801.109)
OR
Over the Counter Use
§ 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).