(109 days)
Not Found
No
The summary describes a mechanical device for compressing oxygen and does not mention any AI/ML related terms or functionalities.
No.
The device is a compressor indicated to supply pressurized oxygen to fill gas cylinders for patient's ambulatory use, but it is explicitly stated that the device is "not intended to be life supporting or life sustaining." It helps in the delivery of a therapeutic substance (oxygen) but is not a therapeutic device itself.
No
The device is described as an oxygen compressor used to fill oxygen cylinders for patients. Its function is to pressurize oxygen, not to diagnose medical conditions or provide information about a patient's health status.
No
The device description clearly states it is an "Oxygen Compressor" and describes its function of accepting low-pressure oxygen and pressurizing it to fill cylinders. This indicates a physical hardware device, not software only. The performance studies also describe bench testing of a physical device.
Based on the provided information, the PureFill Oxygen Compressor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to supply pressurized oxygen to fill gas cylinders for patient's personal ambulatory use. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on the mechanical process of compressing oxygen. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for delivering oxygen for patient use, which falls under the category of medical devices used for treatment or support, not diagnosis.
N/A
Intended Use / Indications for Use
The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining. Environment of use: - Sub-acute care facilities and home settings
Product codes
CAW
Device Description
The PureFill Oxygen Compressor is designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize the oxygen to 2,000 PSIG to fill patient's portable oxygen cylinders.
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
Population is defined not by age but by patients on supplemental oxygen.
Intended User / Care Setting
Sub-acute care facilities and home settings
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)
Non-clinical Testing:
We performed a number of non-clinical tests to demonstrate the safety and efficacy of the PureFill. These tests included:
Materials - The materials utilized are common materials. G95-1 and ISO 10993-1 would categorize the PureFill Oxygen Compressor as:
- External communicating (indirect / gas pathway)
- Mucosa contact
- Permanent duration (> 30 days) .
However, mechanical, pressure generating devices often have materials which cannot be tested by the above listed tests. We performed the following tests: - VOC
- . PM25
- Ozone, CO, and CO2 ●
Performance Testing - We performed equivalent bench testing, including ES60601-1, IEC 60601-1-2, IEC 61000-6-3, EN55011 CISPR 22, Altitude, Fill rate, Oxygen Pressure Surge Testing, Material Selection and Cleaning of Components, Autogenous Ignition Temperature Test, Acoustic Noise, Audible Acoustic Energy. The PureFill Oxygen Compressor performed as intended in each test. These tests were equivalent to the testing required of the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three faces overlapping to suggest a sense of community or interconnectedness. The logo is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Inovo. Inc. c/o Mr. Paul Dryden President ProMedic. Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
Re: K141967
Trade/Device Name: PureFill Oxygen Compressor Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: October 08, 2014 Received: October 10, 2014
Dear Mr. Dryden:
This letter corrects our substantially equivalent letter of November 7, 2014
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.
1
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 of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
PureFill Oxygen Compressor Indications for Use (Describe)
The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.
Environment of use: - Sub-acute care facilities and home settings
XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Page 1 of 2
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Type of Use (Select one or both, as applicable)
EF PSC Publishing Services (301) 443-6740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
3
510(k) Summary Page 1 of 5
8-Oct-14
| Inovo, Inc.
401 Leonard Blvd. North
| Lehigh Acres, FL 33971 | Telephone: 239-643-6577 | |
|---|---|---|
| Official Contact: | Ed Brantley, Manager of Engineering | |
| Proprietary or Trade Name: | PureFill Oxygen Compressor | |
| Common/Usual Name: | Oxygen Compressor | |
| Classification Name: | Portable oxygen generator | |
| CAW – 868.5440 | ||
| Predicate Devices: | Gas Transfill – K091191 | |
| Home Fill II – K003939 | ||
| Device Description: | The PureFill Oxygen Compressor is designed to accept low | |
| pressure (14-30 PSIG) oxygen from existing oxygen | ||
| concentrators and pressurize the oxygen to 2,000 PSIG to fill | ||
| patient's portable oxygen cylinders. | ||
| Indications for Use: | The PureFill Oxygen Compressor is indicated to supply | |
| pressurized oxygen to fill gas cylinders for the patient's personal | ||
| ambulatory use. The device is not intended to be life supporting | ||
| or life sustaining. | ||
| Patient Population: | Patients on supplemental oxygen. | |
| Environment of Use: | Sub-acute care facilities and home settings. | |
| Contraindications: | None |
4
510(k) Summary Page 2 of 5
8-Oct-14
| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| Model Name: | Gas Transfill | Venture IOH 200 Home | |
| Fill II Complete Home | |||
| Oxygen System | PureFill Oxygen | ||
| Compressor | |||
| 510(k) Number | K091191 | K003939 | |
| Indications | The intended use of the Gas | ||
| Transfill System is to | |||
| provide supplemental | |||
| oxygen to patients and to | |||
| supply pressurized oxygen to | |||
| fill gas cylinders for the | |||
| patient's personal ambulatory | |||
| use. |
The device is not intended to
be life supporting nor life
sustaining.
The Transfill System is
comprised of a high pressure
oxygen compressor and an
external oxygen
concentrator. The oxygen
concentrator provides up to
2LPM of gaseous oxygen to
the high pressure oxygen
compressor for filling
medical oxygen cylinders. | The intended function and
use of the Invacare Model
IOH 200 Complete Home
Oxygen System is to provide
supplemental oxygen to
patients and to supply
pressurized oxygen to fill gas
cylinders for the patient's
personal ambulatory use. | The PureFill Oxygen
Compressor is indicated to
supply pressurized oxygen to
fill gas cylinders for the
patient's personal ambulatory
use.
The device is not intended to
be life supporting or life
sustaining.
Environment of use: - Sub-
acute care facilities and
home settings |
| Environment of Use | Home | Home | Sub-acute care facilities and
home settings |
| Patient Population | Patients on supplemental
oxygen | Patients on supplemental
oxygen | Patients on supplemental
oxygen |
5
510(k) Summary Page 3 of 5
8-Oct-14
Specifications / Features
| | Gas Transfill
K091191 | Home Fill II
K003939 | Proposed
PureFill |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Dimensions (l x w x h) | 9" x 20" x 25.5" | 16" x 15" x 16" | 23" x 8in x 12in |
| Weight | 45 lbs | 33 lbs | 33 lbs |
| Sound Level | 44 dBA | Unknown | 55 dBA |
| Power Consumption | 110W | 140W | 110W average |
| Cylinder type | 2,000 and 3,000 PSI | 2,000 PSI | 2,000 PSI |
| Typical filling time | M6* (2,000 PSI)
1 hr 5 min | M6 (2,000 PSI)
1 to 2 hours and 45 minutes | M4 (2,00 PSI)
55 min
M6 (2,000 PSI),
90 min
M9 (2,000 PSI)
135 min
Typical at 22 psi input
pressure |
| OCD/Regulator type | CGA-870 connection | Unknown | CGA-870 Connection |
| Delivers Oxygen to
patient while filling | Yes | Unknown | Yes |
| Input Pressure | Not published | 14-21 psi | 14-30 psig |
| Input flow | Not published | 2 LPM minimum | 2 LPM minimum |
| Compatible
Concentrators | EverFlo, EverFlo Q,
Millennium
M600 and M605 series, and
M10 | Invacare Platinum 5, 10, XL,
and Perfecto2. | Any concentrator that
provides: 14-30 PSIG
2 LPM Minimum
93±3% oxygen |
| Supply Oxygen
Concentration | EverFlo
93% (+/- 3%) (5 LPM)
Millennium M600/605
92% (+/- 4%) 5LPM, 94% (+/-
2%) 2LPM
Millennium M10
92 +/- 4% @ 8-10 LPM
94 +/- 2% @ 3-7 LPM
92 +/- 4% @ 1-2 LPM | Invacare Platinum 5
All 5LXO2/5LX models
87% to 95.6% at 0.5-5 LPM
Invacare Platinum 10
87% to 95.6% at 2-10 LPM
Invacare Perfecto2
87% to 95.6% for flows
ranging at 0.5 to 5 LPM | Any concentrator that
provides: 14-30 PSIG
2 LPM Minimum
93±3% oxygen |
| Oxygen Concentration | 93% (+/- 3%) | >90% | 93±3% |
6
510(k) Summary Page 4 of 5 8-Oct-14
Indicators (alarms)
| Alarm / Alert | Gas Transfill | HomeFill II | Propose
PureFill |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| O2 Concentration | Continuous Green and
Yellow with Flashing Red =
the device has detected a
possible oxygen purity fault
(purity is less than 90%) and
the oxygen within the
cylinder is less than 90%.
System continues to fill | Yellow Light = O2 from
concentrator is 90% | No oxygen alarm. Relies on
concentrator oxygen
monitoring system |
| Over
Pressurization | Not known | Not known | Solid Red FAULT LED and
Continuous Audible Alarm.
Shut off power to motor.
Patient cannot restart unit.
Contact your provider
2200 psig |
Substantial Equivalence Rationale
The Drive Inovo PureFill Oxygen Compressor is viewed as substantially equivalent to the predicate devices because:
Indications - The PureFill Oxygen Compressor is indicated to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting or life sustaining.
This is identical to the predicate - Gas Transfill - K091191, which is intended to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. The device is not intended to be life supporting nor life sustaining.
This is identical to the predicate - Home Fill II - K003939, which is intended to function and use of the Invacare Model IOH 200 Complete Home Oxygen System is to provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use.
Technology - The PureFill Oxygen Compressor is a 2-Stage Positive Displacement compressor designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize the oxygen to 2,000 PSIG. The high pressure oxygen is used to fill portable oxygen cylinders which are for patients' personal ambulatory use only.
7
510(k) Summary Page 5 of 5 8-Oct-14
Environment of Use - The PureFill Oxygen Compressor is designed to be used in sub-acute care facilities and home setting. This is identical to the predicates.
Patient Population - Population is defined not by age but by patients on supplemental oxygen. This is identical to predicate - Home Fill II - K003939 and Gas Transfill - K091191.
Performance Specifications - The PureFill has similar specifications to the predicate for pressurization, fill rate and time, ability to connect to several different concentrators with minimum output requirements. The performance specifications are substantially equivalent to the predicates -Home Fill II - K003939 and Gas Transfill - K091191.
Non-clinical Testing
We performed a number of non-clinical tests to demonstrate the safety and efficacy of the PureFill. These tests included:
Materials - The materials utilized are common materials. G95-1 and ISO 10993-1 would categorize the PureFill Oxygen Compressor as:
- External communicating (indirect / gas pathway)
- Mucosa contact
- Permanent duration (> 30 days) .
However, mechanical, pressure generating devices often have materials which cannot be tested by the above listed tests. We performed the following tests:
- VOC
- . PM25
- Ozone, CO, and CO2 ●
Performance Testing - We performed equivalent bench testing, including ES60601-1, IEC 60601-1-2, IEC 61000-6-3, EN55011 CISPR 22, Altitude, Fill rate, Oxygen Pressure Surge Testing, Material Selection and Cleaning of Components, Autogenous Ignition Temperature Test, Acoustic Noise, Audible Acoustic Energy. The PureFill Oxygen Compressor performed as intended in each test. These tests were equivalent to the testing required of the predicates.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.