(109 days)
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
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.
This document describes the PureFill Oxygen Compressor, a device designed to pressurize low-pressure oxygen from concentrators to fill portable oxygen cylinders. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to previously cleared predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission for a physical medical device (an oxygen compressor), the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices across various aspects, including indications for use, technology, environment of use, patient population, and performance specifications. There are no explicit "acceptance criteria" in terms of clinical accuracy metrics like sensitivity or specificity as would be found for an AI/ML device. Instead, the performance is compared to the predicate devices.
Here's a table summarizing the comparison of the PureFill Oxygen Compressor to its predicate devices, which serves as the "reported device performance" against the implicitly accepted standards of the predicate devices:
| Feature/Specification | Predicate Device (Gas Transfill - K091191) | Predicate Device (Home Fill II - K003939) | PureFill Oxygen Compressor (Proposed Device) |
|---|---|---|---|
| Indications for Use | To provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. Not life supporting/sustaining. | To provide supplemental oxygen to patients and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. | To supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. Not intended to be life supporting or life sustaining. (Identical to predicates) |
| Technology | High pressure oxygen compressor and an external oxygen concentrator. | (Implied similar based on function) | 2-Stage Positive Displacement compressor designed to accept low pressure (14-30 PSIG) oxygen from existing oxygen concentrators and pressurize oxygen to 2,000 PSIG. (Similar principle) |
| Environment of Use | Home | Home | Sub-acute care facilities and home settings. (Expanded but deemed equivalent) |
| Patient Population | Patients on supplemental oxygen | Patients on supplemental oxygen | Patients on supplemental oxygen. (Identical to predicates) |
| Cylinder type | 2,000 and 3,000 PSI | 2,000 PSI | 2,000 PSI |
| Typical filling time (M6, 2000 PSI) | 1 hr 5 min | 1 to 2 hours and 45 minutes | M6 (2,000 PSI), 90 min (M4: 55 min, M9: 135 min) at 22 psi input pressure. (Comparable) |
| OCD/Regulator type | CGA-870 connection | Unknown | CGA-870 Connection. (Similar) |
| Delivers Oxygen to patient while filling | Yes | Unknown | Yes. (Similar) |
| Input Pressure | Not published | 14-21 psi | 14-30 psig. (Comparable or slightly wider range) |
| Input flow | Not published | 2 LPM minimum | 2 LPM minimum. (Similar) |
| 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. (More general, but within predicate capabilities) |
| Supply Oxygen Concentration | (Specifics for various models, generally 92-93% +/- %) | 87% to 95.6% | Any concentrator that provides: 93±3% oxygen. (Similar target oxygen concentration) |
| Oxygen Concentration (Output) | 93% (+/- 3%) | >90% | 93±3%. (Similar) |
| O2 Concentration Alarm | Detects possible oxygen purity fault (< 90%), system continues to fill. | Yellow Light = O2 from concentrator is < 90%. Cylinder filling stops, restarts when O2 >90%. | No oxygen alarm. Relies on concentrator oxygen monitoring system. (Difference, but reliance on upstream device is a design choice that needs to be justified for safety) |
| Over Pressurization Alarm | Not known | Not known | Solid Red FAULT LED and Continuous Audible Alarm. Shuts off power, unit cannot be restarted by patient. Contact provider if > 2200 psig. (Clear safety feature) |
| Sound Level | 44 dBA | Unknown | 55 dBA. (Higher than one predicate, but within typical home appliance/medical device noise levels) |
| Power Consumption | 110W | 140W | 110W average. (Comparable to one, lower than other) |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document details a 510(k) submission for a physical medical device (an oxygen compressor), not a software or AI/ML device. Therefore, the concept of a "test set" with "data provenance" as applied to clinical data (e.g., patient images, electronic health records) is not applicable here.
The "testing" mentioned is primarily non-clinical bench testing to confirm the device meets engineering and safety standards, and performance specifications comparable to predicates. The document does not specify sample sizes in terms of, for example, number of patients or clinical cases.
The non-clinical tests performed included:
- Materials testing (VOC, PM25, Ozone, CO, CO2)
- Performance Bench Testing (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).
These tests are typically conducted in a controlled laboratory environment by the manufacturer or a contracted testing facility, rather than derived from real-world patient data in a specific country. They are prospective tests conducted on prototypes or production units of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As explained above, this is a physical device with non-clinical testing. "Ground truth" in the context of expert medical opinion for diagnostic accuracy is not relevant here. The "truth" for this device's performance is objective measurements from engineering tests (e.g., pressure output, filling time, oxygen concentration verified by laboratory equipment).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no clinical test set requiring expert adjudication for this type of device. Performance is determined by objective measurements against engineering specifications and comparison to predicate device specifications.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. MRMC studies are specific to evaluating the impact of diagnostic aids (often AI) on human reader performance in interpreting medical images or other diagnostic data. This device is an oxygen compressor, not a diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- Engineering Specifications: The device is tested against its own design specifications for parameters like pressure output, fill rates, power consumption, and alarm thresholds.
- International Standards: Compliance with recognized electrical safety, electromagnetic compatibility, and medical device standards (e.g., ES60601-1, IEC 60601-1-2) serves as a "ground truth" for safe operation.
- Predicate Device Performance: The functional and performance characteristics of the legally marketed predicate devices serve as an established benchmark for "acceptable" performance in the market.
8. The sample size for the training set
Not applicable. This is a physical device; there is no "training set" like there would be for an AI/ML algorithm. The device design and manufacturing processes are developed based on engineering principles and regulatory requirements.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this physical device.
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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.
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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
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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.
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510(k) Summary Page 1 of 5
8-Oct-14
| Inovo, Inc.401 Leonard Blvd. NorthLehigh 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 generatorCAW – 868.5440 | |
| Predicate Devices: | Gas Transfill – K091191Home Fill II – K003939 | |
| Device Description: | The PureFill Oxygen Compressor is designed to accept lowpressure (14-30 PSIG) oxygen from existing oxygenconcentrators and pressurize the oxygen to 2,000 PSIG to fillpatient's portable oxygen cylinders. | |
| Indications for Use: | The PureFill Oxygen Compressor is indicated to supplypressurized oxygen to fill gas cylinders for the patient's personalambulatory use. The device is not intended to be life supportingor life sustaining. | |
| Patient Population: | Patients on supplemental oxygen. | |
| Environment of Use: | Sub-acute care facilities and home settings. | |
| Contraindications: | None |
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510(k) Summary Page 2 of 5
8-Oct-14
| Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| Model Name: | Gas Transfill | Venture IOH 200 HomeFill II Complete HomeOxygen System | PureFill OxygenCompressor |
| 510(k) Number | K091191 | K003939 | |
| Indications | The intended use of the GasTransfill System is toprovide supplementaloxygen to patients and tosupply pressurized oxygen tofill gas cylinders for thepatient's personal ambulatoryuse.The device is not intended tobe life supporting nor lifesustaining.The Transfill System iscomprised of a high pressureoxygen compressor and anexternal oxygenconcentrator. The oxygenconcentrator provides up to2LPM of gaseous oxygen tothe high pressure oxygencompressor for fillingmedical oxygen cylinders. | The intended function anduse of the Invacare ModelIOH 200 Complete HomeOxygen System is to providesupplemental oxygen topatients and to supplypressurized oxygen to fill gascylinders for the patient'spersonal ambulatory use. | The PureFill OxygenCompressor is indicated tosupply pressurized oxygen tofill gas cylinders for thepatient's personal ambulatoryuse.The device is not intended tobe life supporting or lifesustaining.Environment of use: - Sub-acute care facilities andhome settings |
| Environment of Use | Home | Home | Sub-acute care facilities andhome settings |
| Patient Population | Patients on supplementaloxygen | Patients on supplementaloxygen | Patients on supplementaloxygen |
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510(k) Summary Page 3 of 5
8-Oct-14
Specifications / Features
| Gas TransfillK091191 | Home Fill IIK003939 | ProposedPureFill | |
|---|---|---|---|
| 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 minM6 (2,000 PSI),90 minM9 (2,000 PSI)135 minTypical at 22 psi inputpressure |
| OCD/Regulator type | CGA-870 connection | Unknown | CGA-870 Connection |
| Delivers Oxygen topatient 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 |
| CompatibleConcentrators | EverFlo, EverFlo Q,MillenniumM600 and M605 series, andM10 | Invacare Platinum 5, 10, XL,and Perfecto2. | Any concentrator thatprovides: 14-30 PSIG2 LPM Minimum93±3% oxygen |
| Supply OxygenConcentration | EverFlo93% (+/- 3%) (5 LPM)Millennium M600/60592% (+/- 4%) 5LPM, 94% (+/-2%) 2LPMMillennium M1092 +/- 4% @ 8-10 LPM94 +/- 2% @ 3-7 LPM92 +/- 4% @ 1-2 LPM | Invacare Platinum 5All 5LXO2/5LX models87% to 95.6% at 0.5-5 LPMInvacare Platinum 1087% to 95.6% at 2-10 LPMInvacare Perfecto287% to 95.6% for flowsranging at 0.5 to 5 LPM | Any concentrator thatprovides: 14-30 PSIG2 LPM Minimum93±3% oxygen |
| Oxygen Concentration | 93% (+/- 3%) | >90% | 93±3% |
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510(k) Summary Page 4 of 5 8-Oct-14
Indicators (alarms)
| Alarm / Alert | Gas Transfill | HomeFill II | ProposePureFill |
|---|---|---|---|
| O2 Concentration | Continuous Green andYellow with Flashing Red =the device has detected apossible oxygen purity fault(purity is less than 90%) andthe oxygen within thecylinder is less than 90%.System continues to fill | Yellow Light = O2 fromconcentrator is < 90% (anytime after three minutewarmup)Cylinder filling stops, willrestart when O2 >90% | No oxygen alarm. Relies onconcentrator oxygenmonitoring system |
| OverPressurization | Not known | Not known | Solid Red FAULT LED andContinuous 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.
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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.
§ 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).