7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT
Device Facts
| Record ID | K020759 |
|---|---|
| Device Name | 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT |
| Applicant | Hans Rudolph, Inc. |
| Product Code | BZD · Anesthesiology |
| Decision Date | Aug 13, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Hans Rudolph 7600 Vmask series is a reusable, single patient multi-use, adult Full-Face CPAP/NIPPV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cmH20 pressure measured at the mask. The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.
Device Story
Full-face mask interface for CPAP/NIPPV therapy; delivers pressurized air to patient airway. Components: mounting headgear, face piece with integrated vent holes, swivel port assembly with anti-asphyxia valve. Used in homes, hospitals, and clinical settings by patients trained on system operation. Input: pressurized gas from CPAP/ventilator blower. Output: patient-delivered air via mask seal. Anti-asphyxia valve allows ambient air breathing if blower fails; vent holes flush CO2. Healthcare providers use mask to maintain airway pressure for OSA or respiratory support. Benefits: non-invasive treatment of sleep apnea/respiratory insufficiency; prevents CO2 rebreathing; provides safety mechanism during flow loss.
Clinical Evidence
No clinical trials performed. Evidence consists of bench testing, human factors studies, and risk assessment. Bench testing included performance verification, biocompatibility testing of silicone rubber, and comparative laboratory studies against predicates. Validated disinfection and sterilization instructions were established for all reusable components.
Technological Characteristics
Reusable full-face mask. Materials: silicone rubber (face piece), nylon/polyester (headgear), polycarbonate (clips), polysulfone (non-contact components). Sensing/Actuation: passive vent holes for CO2 flushing; anti-asphyxia valve for ambient air entrainment. Connectivity: 22 mm swivel port for standard blower tubing. Sterilization: glutaraldehyde and steam. Form factor: five sizes (petite to large).
Indications for Use
Indicated for adult patients (>30 kg) requiring CPAP or non-invasive ventilatory support (≥3.0 cm H2O) for Obstructive Sleep Apnea or other respiratory conditions. Contraindicated for patients with open wounds, hemodynamic/cardiorespiratory instability, unconsciousness, claustrophobia, facial/nasopharyngeal deformity, excessive secretions, impaired cough reflex, hiatal hernia, upper airway obstruction, barotrauma, recent facial/esophageal/gastric surgery, or those requiring immediate intubation or >12 hours/day of support.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- ResMed Sullivan7 Mirage Full Face Mask (K982530)
- Respironics Spectrum Disposable Full Face Mask (K936047)
Related Devices
- K030822 — 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS · Hans Rudolph, Inc. · Jun 3, 2003
- K061653 — SOYALA FULL FACE MASK · Weinmann Gerate Fur Medizin GmbH + Co. KG · Nov 9, 2006
- K043382 — TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 · Tiara Medical Systems, Inc. · Jan 19, 2005
- K243023 — WiZARD 520 Full Face Mask · Wellell, Inc. · May 23, 2025
- K070321 — TWILIGHT FULL FACE MASK · Invacare Corp. · Apr 30, 2007
Submission Summary (Full Text)
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K020759
# SECTION 14: 510(K) SUMMARY
### 1. Summary Preparation Date: August 7, 2001
#### 2. Manufacturer/Applicant Information:
Name: Hans Rudolph, Inc. Company Headquarters and Manufacturing Location: 7205 Central Kansas City, MO 64114 FDA Establishment Registration Number: 1922553 Contact Name and Title Official Correspondent: Kevin Rudolph, Vice President Phone Number: 816-363-5522 Fax Number: 816-822-1414
3. Proprietary Name: 7600 Series Reusable Full-Face CPAP/NIPPV Masks
Model Numbers & Sizes:
a. 7620 Large b. 7630 Medium c. 7640 Small d. 7650 Extra Small e. 7660 Petite Common/Usual Name: Face Mask Classification Name: Noncontinuous Ventilator (IPPB) Accessory Classification Panel: Anesthesiology Classification Code Based on Full-Face Mask Predicates: BZD
4. BZD Device Identification: (21 CFR Part 868.5905): 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. [The device which is the subject of this 510(k) submittal is an accessory to such a device (FDA product code BZD) and also to other bloweroperated ventilation devices with product codes MNT, MNS, and CBK. ]
5. Regulatory Status: Noncontinuous ventilators and their accessories (FDA product code BZD) have been classified by the FDA as class II. Ventilation devices MNT. MNS and CBK have also been classified by the FDA as class II. There are currently no performance standards or special control requirements for any of these devices.
6. Substantial Equivalence: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are substantially equivalent to the ResMed Sullivan7 Mirage Masks (K936047), and the Respironics Spectrum " Reusable Full Face Masks (K961915).
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The characteristics of the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are similar to those of the predicates mentioned above. The few minor differences in technological characteristics do not raise any new questions regarding safety or effectiveness.
Hans Rudolph has created a Design Control Procedure system which is in accordance with ISO 9001, EN 46001, and the FDA Quality System Requirements detailed in 21 CFR 820. It has complied with these Design Control Procedures for all of the verification and validation (V & V) data generated to support the equivalency of this device.
Among the V & V data generated to support the equivalency of the Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks to the predicates is: (a.) risk assessment and reduction analysis. (b.) laboratory studies comparing the performance of the 7600 Series Masks with predicates, (c.) human factors studies, and (d.) laboratory performance verification and validation.
7. General Device Description: The 7600 Series Reusable Full-Face CPAP/NIPPV Masks consists of the following components:
- 1. Mounting Head Gear
- 2. Face Piece with Vent Holes
- 3. Swivel Port Assembly
The Face Piece and the Swivel Port Assembly are both sterilizable and reusable. The Mounting Head Gear is disposable after multiple uses.
The Mounting Head Gear is adjustable in both its size and tension and holds the Face Piece against the patient's face to prevent any gas leakage. The size range of adjustment have been determined by a Mask Human Factors Study. The Mounting Head Gear also holds both the Face Piece and the Swivel Port Assembly onto the patient's head and is capable of adjusting to varying head sizes as determined by the Mask Human Factors Study.
The physical properties and dimensional ranges of the Face Piece (Mask) sizes listed under section #3 above have been determined by a Mask Human Factors Study.
All Face Piece sizes incorporate a series of vent holes in the area of the nose to provide a continuous air leak to flush out the dead space CO2 and prevent it from being rebreathed by the patient. The incorporation of these holes do not interfere with the other performance requirements of the 7600 Series Mask. The vent holes also function to allow the patient to exhale normally regardless as to whether he or she is connected to single or dual level CPAP system or an MNT. MNS or CBK ventilator and regardless of the make or model of the CPAP or MNT. MNS or CBK ventilator blower device being used.
The Swivel Port Assembly consists of the following pieces:
- 1. Mask Adapter
- 2. Elbow with Anti-Asphyxia Valve
- 3. 22 mm Swivel Port
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The 22 mm Swivel Port is sized to connect to all standard CPAP or MNT, MNS or CBK ventilator blower tubing types. The Elbow provides 360° of swivel rotation both at the Mask Adapter and at the 22 mm Swivel Port. The Anti-Asphxyia Valve is detachable from the Elbow for cleaning, sterilization and replacement.
The Anti-Asphxyia Valve functions as a safety mechanism which allows the patient to breathe fresh air if the CPAP or MNT, MNS, or CBK ventilator blower output ceases.
### 8. Intended Use, Indications for Use, & Environment:
Intended Use: The Hans Rudolph 7600 Vmask Series is a reuseable, single patient multi –use, adult Full-Face CPAP/NPPV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is intended for use with certain CPAP machines for treatment of obstructive sleep annea, and for use with other similators that use this exhaust port configuration providing a minimum of 3 cm H2O pressure measured at the mask.
Environment of Use: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are for use in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the device and system to which the masks are intended to connect.
Indications for Use: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support at pressures > 3.0 cm H2O at the mask in homes, hospitals, and other clinical settings.
Contraindications: The masks will not remain sterile between repeated single-patient uses and should not be placed over open wounds that are prone to infection. Cleaning, disinfection, and sterilization procedures are included as part of the Instructions for Use.
The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks may not be suitable for use on patients with the following conditions:
- 1. a minimum pressure < 3 cm H2O at mask
- 2. open wounds that are prone to infection
- 3. hemodynamic or cardiorespiratory instability
- 4. unconsciousness
- 5. claustrophobia, anxiety, or other discomfort with full-face mask
- 6. facial or nasopharyngeal deformity, beard, or other inability to fit mask & seal properly
- 7. excessive reflux, GI blood, or other secretions
- 8. impaired cough reflex, hiatal hernia, or inability to swallow or clear secretions
- 9. upper airway obstruction or facial trauma
- 10. barotrauma
- 11. need for ventilation or ventilatory support more than 12 hours per day
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- 12. recent facial, esophageal, or gastric surgery
- 13. patients unable to remove mask
- 14. patients under medication with a drug that may cause vomiting
- 15. patients requiring immediate intubation
Complications: The Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks are non-invasive devices. The silicone surface which is applied directly to the patient's soft, pliable and a biocompatible material. The masks are safe in both construction and use. This has been confirmed by the performance of Verification and Validation Testing. Biocompatibility Testing, Risk Assessment Analysis, and Comparative Testing.
Following are some possible minor to moderate complications:
- 1. infection due to improper use over open wounds
- 2. skin irritation after prolonged use caused by rubbing of the mask
- 3. nasal or dental pain or deformity
- 4. drying of pharvngeal and nasal mucosa
- 5. eve irritation or conjunctivitis
- 6. gastric distention and abdominal pain or flatulence from ingested air
- 7. some slight discomfort after prolonged use
- 8. decreased secretion clearance especially during upper respiratory tract infections
- 9. aspiration of secretions
9. Device Materials: The mask Face Piece, which contacts the patient's skin, is constructed of silicone rubber (latex-free). This material has successfully undergone biocompatibility testing at a nationally recognized biological testing laboratory. The mask Head Gear materials consist of nylon and polyester straps and polycarbonate clips. All other components which are not in contact with the patient's skin are constructed of polysulfone material. All mask components other than the Head Gear are capable of both glutaraldehyde and steam sterilization.
10. Comparison Table: The table that follows describes the important characteristics of the 7600 Series Reusable Full-Face CPAP/NIPPV Masks and three claimed predicates: ResMed Sullivan7 Mirage™ Full Face Masks (K982530), Respironics Spectrum™ Reusable Full Face Masks (K961915), and Respironics Spectrum The Disposable Full Face Masks (K936047) [Characteristics of the Respironics disposable mask are mostly identical to the Respironics reusable mask, exceptions for the disposable mask are indicated in brackets]. The similarities and differences between the 7600 Series Reusable Full-Face CPAP/NIPPV Masks and its predicates are shown in the "Similar/Different" column. The differences are always shown at the bottom section of each "Similar/Different" cell and are shown in bold type.
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| # | Characteristic | ResMed Sullivan7 MirageTM Full Face Mask | Respironics SpectrumTM Reusable and Disposable Full Face Mask [Disposable Exceptions] | 7600 Series Reusable Full-Face CPAP/NIPPV Masks<br>Similar/Different |
|---|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | intended use | adult patient interface accessory for use with CPAP, bilevel, or ventilation support systems | connect adult or pediatric patients to CPAP, BiPAP, or ventilation support system designed to augment the patient's ability to breathe on a spontaneous basis | connect adult patients to single and dual level CPAP devices and to non-invasively connect adult patients to blower-operated respiratory support ventilators |
| 2 | indications | obstructive sleep apnea (OSA), respiratory insufficiency, and/or respiratory failure | respiratory failure, respiratory insufficiency, and/or obstructive sleep apnea | obstructive sleep apnea or any other conditions requiring CPAP or non-invasive ventilatory support |
| 3 | environment | hospitals, homes, and clinical settings | hospital, homes, and institutions | homes, hospitals, and other clinical settings |
| 4 | personnel education and training | individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect | individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect | individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect |
| 5 | reuse | single patient multi-use | single patient multi-use [disposable] | single patient multi-use |
| 6 | safety mechanisms | anti-suffocation valve to guard against loss of flow source; mask quick-release feature to guard against aspiration or suffocation; mask vent holes to prevent CO2 buildup | entrainment valve to guard against loss of flow source; mask quick-release feature to guard against aspiration or suffocation | safety breathe-out valve to guard against loss of flow source; mask pull-string release feature to guard against aspiration or suffocation; mask vent holes to prevent CO2 buildup |
| 7 | anti-suffocation valve threshold | 3.0 cm H2O minimum | 3.0 cm H2O minimum | 3.0 cm H2O minimum |
ഗ്ര
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| # | Characteristic | Predicate devices | ResMed Sullivan7 MirageTM Full Face Mask | Respironics SpectrumTM Reusable and Disposable Full Face Mask [Disposable Exceptions] | 7600 Series Reusable Full-Face CPAP/NIPPV Masks | Similar/Different |
|----|------------------------------------------|-------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| 8 | fastening<br>means | | headgear straps | headgear straps | mounting head gear straps | |
| 9 | mask sizes | | three sizes (small, medium & large) fit a range of adult patients | four sizes (petite, small, medium & large) fit a range of adult patients | five sizes (petite, extra small, small, medium, & large) fit a range of adult patients | Model 7600 series has one more size than Respironics and two more sizes than ResMed to ensure a good fit |
| 10 | mask material<br>in contact with<br>face | | silicone rubber; soft, comfortable, latex-free | silicone rubber [vinyl]; comfortable | soft biocompatible silicone rubber (latex-free)<br>SpectrumTM Disposable uses vinyl | |
| 11 | cleaning instructions | | yes | yes [no] | yes | Respironics Disposable has none |
| 12 | validated disinfection instructions | | instructions exist (not known if these are validated) | such instructions found only for exhalation valve (validation status unknown) [no] | | Model 7600 series has validated disinfection instructions for all reusable mask components |
| 13 | validated sterilization instructions | | none known to exist | validated instructions found only for exhalation valve component [no] | | Model 7600 series has validated sterilization instructions for all reusable mask components |
| 14 | sterility at<br>shipment | | provided clean, non-sterile | provided clean, non-sterile | provided clean, non-sterile | |
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| # | Characteristic | ResMed Sullivan7 Mirage™ Full Face Mask | Respironics Spectrum™ Reusable and Disposable Full Face Mask [Disposable Exceptions] | 7600 Series Reusable Full-Face CPAP/NIPPV Masks<br>Similar/Different |
|----|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 15 | contraindications listed in labeling | a minimum pressure < 3 cm H2O at the mask; impaired cardiac sphincter function; excessive reflux; impaired cough reflex; hiatus hernia; insufficient arousability; insufficient capability to remove mask; uncooperative, obtunded, or unresponsive patients | a minimum pressure < 3 cm H2O at the mask; uncooperative, obtunded, or unresponsive patients; impaired cardiac sphincter function; excessive reflux; impaired cough reflex; hiatal hernia; patients unable to remove mask; patients under medication with a drug that may cause vomiting | min P < 3 cm H2O at mask; open wounds that are prone to infection; hemodynamic or cardiorespiratory instability; unconsciousness; claustrophobia, anxiety, or other discomfort with full-face mask; facial or nasopharyngeal deformity, beard, or other inability to fit mask & seal properly; excessive reflux, GI blood, or other secretions; impaired cough reflex, hiatal hernia, or inability to swallow or clear secretions; upper airway obstruction or facial trauma; barotrauma; need for ventilation or ventilatory support more than 12 hours per day; recent facial, esophageal, or gastric surgery; patients unable to remove mask; patients under medication with a drug that may cause vomiting; patients requiring immediate intubation<br>more contraindications are recognized and these should also apply to predicates |
| 16 | complications listed in labeling | infection due to improper use over open wounds; skin irritation after prolonged use caused by rubbing of the mask; some slight discomfort after prolonged use; aspiration of secretions; allergic reaction; stomach distention | infection due to improper use over open wounds; skin irritation after prolonged use caused by rubbing of the mask; some slight discomfort after prolonged use; aspiration of secretions; allergic reaction; stomach distention; belching | infection due to improper use over open wounds; skin irritation after prolonged use caused by rubbing of the mask; nasal or dental pain or deformity; drying of pharyngeal and nasal mucosa; eye irritation or conjunctivitis; gastric distention and abdominal pain or flatulence from ingested air; some slight discomfort after prolonged use; decreased secretion clearance especially during upper respiratory tract infections; aspiration of secretions<br>more details are given on complications and these should also apply to predicates |
| # | Characteristic | ResMed Sullivan7 MirageTM Full Face Mask | Respironics SpectrumTM Reusable and Disposable Full Face Mask [Disposable Exceptions] | 7600 Series Reusable Full-Face CPAP/NIPPV Masks<br>Similar/Different |
| 17 | assemblies | headgear; mask (includes mask cushion, cushion clip, port cap, mask frame, mask port, port cap, & air vent); and valve (includes valve frame, valve membrane, valve clip, valve elbow, tab, swivel, & swivel clip) | headgear; full face mask (includes face mask, adjustable forehead tab, entrainment valve, quick release tab, quick release cord, and pressure pick-off port cap); and exhalation valve | mounting head gear; face piece with vent holes; and swivel port assembly (includes mask adapter, elbow with anti-asphxyia valve, and 22 mm swivel port) |
| 18 | material of mask shell & other pieces not in contact with face (excludes anti-suffocation valve) | transparent polycarbonate or acrylic | transparent polycarbonate or acrylic | transparent polysulfone |
| 19 | service life | unknown | unknown | 2 years |
| 20 | maximum operating pressure | ResMed Sullivan7 VPAP7 series flow generators are rated at 25 cm H2O maximum operating pressure. The MirageTM Reusable Full Face Mask is used as a patient connection means. | Respironics Esprit ventilator is rated at 35 cm H2O maximum operating pressure. The Spectrum Reusable Masks are used as patient connection means. [Respironics Vision is rated at 40 cm H2O maximum operating pressure. The Spectrum Disposable Masks are used as patient connection means.] | Model 7600 is capable of meeting all its specifications while operating at a maximum pressure of 40 cm H2O |
| 21 | carbon dioxide rebreathing | built-in air leak provided by series of holes in mask near nose flushes CO2 out of mask | continuous air leak from exhalation valve helps to flush CO2 out of mask | built-in air leak provided by series of holes in mask near nose flushes CO2 out of mask |
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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. There is a logo to the left of the text that is a stylized version of the HHS logo.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## AUG 1 3 2002
Mr. Kevin Rudolph Vice President Hans Rudolph, Incorporated 7205 Central Kansas City, Missouri 64114
Re: K020759
Trade/Device Name: 7600 Series Reusable Full-Face CPAP/NIPPV Masks Regulation Number: 868.5905 Regulation Name: Accessory to Non-Continuous Ventilator Regulatory Class: II Product Code: BZD Dated: June 12, 2002 Received: June 14, 2002
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.
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.
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Page 2 - Mr. Rudolph
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646 . 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.
Patricia Cacciato for
Timothy A. Ulatowski 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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Page__________________________________________________________________________________________________________________________________________________________________________
#### SECTION 5: INDICATIONS FOR USE STATEMENT
510(k) Number (if known) K020759
Device Name: Hans Rudolph 7600 Series Reusable Full-Face CPAP/NIPPV Masks
Indications For Use:
The Hans Rudolph 7600 Vmask series is a reusable, single patient multi-use, adult Full-Face CPAP/NIPPV mask which incorporates a passive, continuous flow exhaust port at the patient connection. It is intended for use with certain CPAP machines for treatment of obstructive sleep apnea, and for use with other similar ventilators that use this exhaust port configuration providing a minimum of 3 cmH20 pressure measured at the mask.
The Masks are specifically indicated for use on adult patients (> 30 kilograms weight) for treatment of Obstructive Sleep Apnea or any other conditions requiring CPAP or non-invasive ventilatory support (at pressures ≥ 3.0 cm H2O at the mask) in homes, hospitals, and other clinical settings by individuals that have received at least minimal instruction or training on the use of the masks as well as the device and system to which the masks are intended to connect.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K020759 |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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