(504 days)
Not Found
No
The description focuses on a "Pressure Variation Algorithm" and "expiration pressure release," which are standard features in CPAP devices and do not indicate the use of AI/ML. There is no mention of AI, ML, or related terms in the document.
Yes
The device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients, which is a therapeutic purpose.
No
This device is a CPAP machine intended for the treatment of Obstructive Sleep Apnea, not its diagnosis. Its purpose is to deliver positive airway pressure for therapeutic benefit.
No
The device description explicitly states it is a "XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720" and mentions sharing the same "construction" as a predicate device, indicating it is a physical hardware device that includes software (firmware) for its operation. The performance studies also include hardware-related testing like Safety and EMC.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a CPAP machine that delivers air pressure to the patient's airway. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD-related information: The document does not mention any of the typical elements associated with IVDs, such as:
- Analysis of biological samples
- Detection or measurement of substances in the body
- Diagnostic claims
- Performance metrics like sensitivity, specificity, etc., in the context of diagnosing a condition.
The device is clearly intended to treat a condition (OSA) by providing mechanical support to the airway, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for use in the home or hospital/institutional environment.
Product codes (comma separated list FDA assigned to the subject device)
70-573, 73 BZD
Device Description
XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720 is intended to be used to deriving continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) in adult patients and home environment. It is a modification of XT Auto CPAP Model 9S-005200(K083656). It shares the same construction and auto adjustment algorithm with XT Auto CPAP but adds expiration pressure release with three constant levels in firmware and has the same downloading function as XT Auto CPAP. XT Auto CPAP with Pressure Variation Algorithm provides a release pressure during expiration phase; it is equivalent to Expiratory Pressure Relief (EPR) of the predicate device RESMED S8 ADVANCE (K082979).
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
Adult
Intended User / Care Setting
home or hospital/institutional environment.
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)
Design verification tests were performed on the new device with the predicate device(s) as a result of the risk analysis and product requirements. The verified items are as following:
- (1) Safety and EMC: according to XT Auto CPAP (K083656) testing procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1& IEC 60601-1-2.
- (2) FDA Draft Reviewer Guidance for Ventilators (July 1995)
- (3) FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- Side by side waveform testing at various pressure and frequency levels with the (4) predicate device(s)
- (5) Closed-loop control analysis.
Above tests were verified to meet the required acceptance criteria. We have determined that the new device has the same safety and effectiveness features. In summary, the device described in this submission is substantially equivalent to the predicate devices.
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.
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
112074
Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 9S-005720 510/k) Premarket Notification Section E - 510(k) Summary
510(k) Summary for Safety & Effectiveness
Date Prepared: 28th September, 2012
DEC 0 6 2012
Applicant name: Apex Medical Corp.
Contact Person Alan Chang
Address:
9, Min Sheng St. Tu-Cheng, Taipei County, Taiwan, R.O.C.
886-2-22683100 Phone number:
886-2-22686525 Fax numbers:
Device name
· Trade name: Apex medical XT Auto CPAP with Pressure Variation Algorithm 9S-005720
Common name: CPAP
Classification name:
Non-continuous ventilator Class II in accordance with 21 CFR 868.5905
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Classification
Regulation Number: 868.5905
Medical Specialty: Anesthesiology
Product Code: 70-573
Product Code: 73 BZD
Device Class: II
| SE 510(k) number | RESMED | S8 ADVANCE | (K082979) |
|---|---|---|---|
| Apex Medical | XT Auto CPAP | (K083656) |
Reason for Submission
New Device
E-I
1
Indications for Use:
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for use in the home or hospital/institutional environment.
Device Description:
XT Auto CPAP with Pressure Variation Algorithm Model 9S-005720 is intended to be used to deriving continuous positive airway pressure (CPAP) for Obstructive Sleep Apnea (OSA) in adult patients and home environment. It is a modification of XT Auto CPAP Model 9S-005200(K083656). It shares the same construction and auto adjustment algorithm with XT Auto CPAP but adds expiration pressure release with three constant levels in firmware and has the same downloading function as XT Auto CPAP. XT Auto CPAP with Pressure Variation Algorithm provides a release pressure during expiration phase; it is equivalent to Expiratory Pressure Relief (EPR) of the predicate device RESMED S8 ADVANCE (K082979).
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device(s)
- A Similar intended use
-
Similar operating principle
- A Similar technology
-
Similar manufacturing process
2
| Device
Characteristic | XT Auto CPAP
with Pressure
Variation
Algorithm
9S-005720 | Predicate1
RESMED S8
ADVANCE
(K082979) | Predicate2
XT Auto CPAP
9S-005200
(K083656) | Comment |
|-------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended user | Adult | Adult | Adult | Equivalent |
| Outlook | | | | Subject is the
same as
Predicate 2
(K083656),
Outlook is no
effect on
performance. |
| Dimensions
(HxWxD) | 14.5 x 13.0 x 10.0 cm | 11.2x16.4x14.5 cm | 14.5 x 13.0 x 10.0 cm | Subject is the
same as
Predicate 2
(K083656) |
| Weight | 0.8kg | 1.4kg | 0.8kg | Subject is the
same as
Predicate 2
(K083656) |
| Tubing | Silicon, 1 x
6'/180cm length | Flexible plastic
6'6" 2 m length | Silicon, 1 x
6'/180cm length | Subject is the
same as
Predicate 2
(K083656) |
| Air Outlet | 22mm | 22mm | 22mm | Equivalent |
| Power Source | 100 ~ 240 VAC,
50/60Hz, 60/65
W | 100 ~ 240 VAC,
50/60 Hz | 100 ~ 240 VAC,
50/60Hz, 60/65
W | Equivalent |
| Safety
Classification | IEC60601-1
Class II | IEC60601-1
Class II | IEC60601-1
Class I | All comply
with
IEC60601-1 |
| User | Single-user,
multi-use | Single-user,
multi-use | Single-user,
multi-use | Equivalent |
| Operating
Environment | +5 ~ 35℃
15 ~ 95%
Non-condensing | +5 ~ 36℃
10 ~ 95% | +5 ~ 35℃
15 ~ 95%
Non-condensing | Subject is the
same as
Predicate 2
(K083656) |
| Pressure | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | 4 ~ 20 cmH2O | Equivalent |
| Device
Characteristic | XT Auto CPAP
with Pressure
Variation
Algorithm
9S-005720 | Predicate1
RESMED S8
ADVANCE
(K082979) | Predicate2
XT Auto CPAP
9S-005200
(K083656) | Comment |
| Range | | | | |
| Pressure
Increment | 0.5 cmH2O | 0.5 cmH2O | 0.5 cmH2O | Equivalent |
| Pressure
setting | Complex buttons | Complex
buttons | Complex
buttons | Subject is the
same as
Predicate
2(K083656),
and equivalent
to Predicate
1(K082979) |
| Pressure
Ramp Time | 045 min, 545 min, 5
minutes per step | 0
minutes per
step | 0~45 min, 5
minutes per
step | Equivalent |
| Display | LCD display | LCD display | LCD display | Equivalent |
| Pressure
Compensate | Yes | Yes | Yes | Equivalent |
| Altitude
Compensate | Yes | Yes | Yes | Equivalent |
| Operation
Altitude | Up to 8000ft | Sea level to
8500ft | Up to 8000ft | Subject is the
same as
Predicate 2
(K083656) |
| Leak
Compensate | Yes | Yes | Yes | Equivalent |
| Data Transfer | By miniUSB | By Data Card &
DB9 adaptor | By miniUSB | Subject is the
same as
Predicate 2
(K083656),
besides, Data
transfer is no
effect on
performance. |
| Leak Alert | Yes | Yes | Yes | Equivalent |
| Automatically
Titrates
Pressure in
APAP mode | Yes | Yes | Yes | Equivalent
and Subject is
the same as
Predicate 2
(K083656) |
| Humidity | Yes | Yes | Yes | Equivalent |
| Device
Characteristic | XT Auto CPAP
with Pressure
Variation
Algorithm
9S-005720 | Predicate1
RESMED S8
ADVANCE
(K082979) | Predicate2
XT Auto CPAP
9S-005200
(K083656) | Comment |
| compatibility | | | | |
| Expiration
Pressure
Release | Yes
Three Constant
Levels (1, 2, 3
cmH2O) | Yes
Three Constant
Levels(1,2,3
cmH2O) | No | Subject is
equivalent to
Predicate1
(K082979) |
Table of comparison with predicates
3
Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 95-005720
: ・
・
:
E-4
4
Design verification tests were performed on the new device with the predicate device(s) as a result of the risk analysis and product requirements. The verified items are as following:
- (1) Safety and EMC: according to XT Auto CPAP (K083656) testing procedures, including FDA reviewer guidance 638.pdf, IEC 60601-1& IEC 60601-1-2.
- (2) FDA Draft Reviewer Guidance for Ventilators (July 1995)
- (3) FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- Side by side waveform testing at various pressure and frequency levels with the (4) predicate device(s)
- (5) Closed-loop control analysis.
Above tests were verified to meet the required acceptance criteria. We have determined that the new device has the same safety and effectiveness features. In summary, the device described in this submission is substantially equivalent to the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 6, 2012
Mr. Alan Chang Senior Director of Quality Management Division Apex Medical Corporation Number 9, Minsheng Street Tucheng City, Taipei County 236 Taiwan, China
.
Re: K112079
Trade/Device Name: XT Auto CPAP with Pressure Variation Algorithm 9S-005720 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 28, 2012 Received: October 1, 2012
Dear Mr. Chang:
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.
6
Page 2 - Mr. Chang
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 (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.
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/CDRH0ffices/ucm] 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,
Kwame Ⓞ. Ulmer
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
7
Apex Medical Corp. XT Auto CPAP with Pressure Variation Algorithm 95-005720 510(k) Premarket Notification Revised Section D - Statement of Indications for Use
Indications for Use
510(k) Number: _ K112079
XT Auto CPAP with Pressure Variation Algorithm 9S-005720 Device Name:
Indications for Use:
This device is intended to provide continuous positive airway pressure (CPAP) for the treatment of adult Obstructive Sleep Apnea (OSA) patients who are spontaneously breathing. It is intended for use in the home or hospital/institutional environment.
Over-The-Counter Use AND/OR Prescription Use _ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lester W. Schultheis Jr 2012.12.04 11:23:55 -05'00'
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
K112079 510(k) Number;
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