Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on physical and chemical filtration mechanisms, with no mention of AI or ML technologies.

Therapeutic

No.
This device is a filter intended to reduce contaminants from gas lines used in assisted reproduction technologies, not to directly treat or diagnose a medical condition in a patient.

Diagnostic

No

The device is a gas line filter intended to reduce contaminants in supply gas lines for incubators and workstations used in assisted reproduction technologies. It performs a filtration function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly details physical components like HEPA and Activated Carbon filter media encased in a polypropylene shell, quick-connections, clamps, and a magnetic holding bracket. Performance studies also focus on physical properties like structural integrity and filtration efficiency.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is to filter supply gas lines for incubators and workstations used in assisted reproduction technologies and IVF procedures. This is a supporting function for the IVF process itself, not a diagnostic test performed in vitro on biological samples.
Device Description: The device is a filter designed to remove contaminants from gas. It does not interact directly with biological samples for the purpose of diagnosis.
Lack of Diagnostic Function: The device does not perform any analysis or measurement of biological samples to provide diagnostic information about a patient's condition or state.
Target User: The intended users are embryologists, who are involved in the process of IVF, not typically in performing diagnostic tests on patients.

While the device is used in the context of IVF, which involves in vitro procedures, the device itself is a gas filtration system and does not meet the definition of an IVD, which is a device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Origio Gas Line Filter is intended for the reduction of volatile organic compounds (VOC's), and particulate contaminants from supply gas lines to incubators and work stations that are used in assisted reproduction technologies and/or In vitro fertilization procedures.

Product codes (comma separated list FDA assigned to the subject device)

MQG

Device Description

The Origio Gas Line Filter combines a High Efficiency Particulate Air (HEPA) Filter Media and an Activated Carbon Media Filter which is impregnated with Potassium Permanganate (KMNO4). The 1.5", 0.5um Glass Fiber HEPA Media is designed to remove particulates from the supply gas, №2, СО₂ or TriGas (N₂, CO₂ and O₂ ) blend which is commonly used in IVF Incubators and other IVF work stations. The 3.5" Potassium Permanganate – Impregnated Activated Carbon Fiber Felt Media is designed to remove Volatile Organic Compounds (VOC's) from the supply gas provided to the IVF Incubator/Work Station.

The HEPA Filter Media and the Activated Carbon Filter Media are encased in a polypropylene outer shell creating a capsule for the filtration of the medical supply gas. The Origio Gas Line Filter is designed to be installed between the supply gas and the IVF Incubator/Work station utilizing the integrated ¼" male and ¼" female quick- connections. Quick disconnect "intake and output fittings" and clamps are provided along with a magnetic holding bracket for easy installation on to the supply gas line. The Origio Gas Line Filter is provided non-sterile and is individually vacuum packed in a double poly bag.

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

Not Found

Intended User / Care Setting

Embryologists in IVF and ART Laboratories

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)

Performance testing was conducted on the Origio Gas Line Filter demonstrating the overall structural integrity, filtration efficiency and the effectiveness in the reduction/removal of Volatile Organic Compounds. Structural integrity testing included the following: Flow Rate and Pressure Drop, Diffusion and Bubble Point and Burst Pressure.

Particle filtration efficiency testing was conducted using an industry standard test method to demonstrate the filters met HEPA and ULPA requirements. Particle filtration efficiency was conducted with new filters, aged filters and filters that were challenged with a simulated particle load representing 6 months of use life based upon reported "source air" particle levels found in typical IVF Laboratories.

VOC removal efficiency testing was performed using a challenge supply gas concentration containing 17 different VOCs based upon the published literature for the reported VOC levels found in the typical IVF Laboratory. VOC removal efficiency values for the Origio Gas Line Filter was demonstrated up to the 6-month use life for new and aged filters. Additional VOC efficiency testing was conducted confirming that filters which had already been in service in IVF laboratories for 6 months were still effective in removing VOC's at the end of their actual "Use Life".

Mouse Embryo Assay testing of the Origio Gas Line Filter was conducted with the Origio Gas Line Filter installed on the incubator gas supply line to provide verification that the use of Origio Gas Line Filter does not negatively impact or effect mouse embryo development.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

HEPA filter must capture a minimum of 99.97% of particulate contaminants at 0.3 microns in size.
Actual Efficiency - The Origio Filter meets requirements for both ULPA (Ultra Low Penetration Air) and HEPA (High Efficiency Particulate Air) with >= 99.999% efficiency for particle sizes between 0.1-0.2 microns and 0.2-0.3 microns throughout the 3 year shelf life.
Use Life of up to 6 months was demonstrated with filtration efficiencies meeting both ULPA and HEPA requirements for filters challenged with a worse case particle load simulating 6 months of usage in an IVF Lab.
Testing demonstrates >99% efficiency up to a 6 month "use life" for VOC removal.

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.

K001486

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

Regulation Number and Section

§ 884.6120 Assisted reproduction accessories.

(a)
Identification. Assisted reproduction accessories are a group of devices used during assisted reproduction procedures, in conjunction with assisted reproduction needles and/or assisted reproduction catheters, to aspirate, incubate, infuse, and/or maintain temperature. This generic type of device may include:(1) Powered aspiration pumps used to provide low flow, intermittent vacuum for the aspiration of eggs (ova).
(2) Syringe pumps (powered or manual) used to activate a syringe to infuse or aspirate small volumes of fluid during assisted reproduction procedures.
(3) Collection tube warmers, used to maintain the temperature of egg (oocyte) collection tubes at or near body temperature. A dish/plate/microscope stage warmer is a device used to maintain the temperature of the egg (oocyte) during manipulation.
(4) Embryo incubators, used to store and preserve gametes and/or embryos at or near body temperature.
(5) Cryopreservation instrumentation and devices, used to contain, freeze, and maintain gametes and/or embryos at an appropriate freezing temperature.
(b)
Classification. Class II (special controls) (design specifications, labeling requirements, and clinical testing). The device, when it is a simple embryo incubator with only temperature, gas, and humidity control; a syringe pump; a collection tube warmer; a dish/plate/microscope stage warmer; a controlled-rate cryopreservation freezer; or an assisted reproduction laminar flow workstation is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

Summary

0

MAY 0 7 2014

510(k) Summary: K132870

510(k) Summary in accordance with the requirements of 21 CFR 807.92

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

| Submitter: | Origio Inc.
2400 Hunters Way
Charlottesville, VA 22911 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Clay
Director, Regulatory Affairs
Origio Inc.
77 Elbo Lane
Mount Laurel, NJ 08054
Phone – (800) 648-1151 or (856) 762-2000 |

Fax - (856) 762-2009

Date Prepared: April, 24 2014

Device Information

Trade Name:	Origio Gas Line Filter
Common/Usual Name:	Gas Line Filter
Classification:	Class II
Classification Panel:	Obstetrics/Gynecology
Regulation Number:	21 CFR 884.6120
Regulation Name:	Accessories, Assisted Reproduction
Product Code:	MQG

Predicate Device

Origio has compared the Origio Gas Line Filter to the CODA Inline Filter, which was included as part of 510(k) K001486 for the CODA Air Purification System, submitted by International Company.

Origio Gas Line Filter - Traditional 510(K)

1

Device Description

The Origio Gas Line Filter combines a High Efficiency Particulate Air (HEPA) Filter Media and an Activated Carbon Media Filter which is impregnated with Potassium Permanganate (KMNO4). The 1.5", 0.5um Glass Fiber HEPA Media is designed to remove particulates from the supply gas, №2, СО₂ or TriGas (N₂, CO₂ and O₂ ) blend which is commonly used in IVF Incubators and other IVF work stations. The 3.5" Potassium Permanganate – Impregnated Activated Carbon Fiber Felt Media is designed to remove Volatile Organic Compounds (VOC's) from the supply gas provided to the IVF Incubator/Work Station.

The HEPA Filter Media and the Activated Carbon Filter Media are encased in a polypropylene outer shell creating a capsule for the filtration of the medical supply gas. The Origio Gas Line Filter is designed to be installed between the supply gas and the IVF Incubator/Work station utilizing the integrated ¼" male and ¼" female quick- connections. Quick disconnect "intake and output fittings" and clamps are provided along with a magnetic holding bracket for easy installation on to the supply gas line. The Origio Gas Line Filter is provided non-sterile and is individually vacuum packed in a double poly bag.

Indication for Use

The Origio Gas Line Filter is intended for the reduction of volatile organic compounds (VOC's), and particulate contaminants from supply gas lines to incubators and work stations that are used in assisted reproduction technologies and/or In vitro fertilization procedures.

Technological Characteristics Comparison

The materials of construction and design features of the Origio Gas Line Filter are very similar to the predicate Coda InLine filter. The capsule size for both filters are also comparable in that the Origio Filter has a 5 ½ inch long capsule and the Coda InLine Filter capsule is approximately 6½ inches long. Each filter is designed with integral ¼ inch male and female quick disconnect features to enable easy installation on to the supply gas line.

Each filter has an activated carbon filter component and a HEPA filter media component contained in a capsule that is placed on the gas line supplying N2 CO2 or TriGas (N2, CO2 and O2) blend. The main difference between the Origio filter and the predicate CODA filter is the addition of potassium permanganate (KMNQ4), which is impregnated into the rolled activated carbon fiber felt component contained in the Origio Gas Line Filter, as an additional measure to reduce VOC's which can be found in the supply gas lines.

Origio Gas Line Filter - Traditional 510(K)

2

origin

The activated carbon and the potassium permanganate contained in the Origio Gas Line Filter are not loose or granulated and do not pass through the secondary particle filter. The particle filtration testing conducted has demonstrated that this secondary filter meets ULPA efficiency requirements. Additionally, there were no toxic effects observed with cultured embryos while using the Origio Gas Line Filters on the incubation system utilized for Mouse Embryo Assay testing. Therefore, we believe the use of the potassium permanganate within the Activated Carbon filter component of the Origio Gas Line Filter does not pose additional safety or effectiveness questions as compared to the predicate device.

While there are differences in the construction and materials of the capsule filter with respect to the HEPA/ULPA filter and the activated carbon (Granulated Activated Carbon for the CODA Filter vs. Rolled Carbon fiber felt/with impregnated KMNO4 for the Origio Filter), the intended purpose of these filtering components are the same, which is to remove VOC's, and particulate contaminants from the supply gas. Both the Origio Gas Line Filter and the predicate Coda InLine Filter are used in the same manner and for the same intended purpose as an accessory to the IVF incubator system and/or workstation by filtering VOC's and particulate contaminants from the supply gas lines, which are used in assisted reproduction technologies and/or In vitro fertilization procedures.

Device Name	Origio Gas Line Filter	(CODA InLine Filter)
510(k) Number	Subject 510(k)	K001486
CODA Air Purification System
Indication for Use	The Origio Gas Line Filter is intended for the
reduction of volatile organic compounds (VOC's),
and particulate contaminants from supply gas
lines to incubators and work stations that are
used in assisted reproduction technologies and/or
In vitro fertilization procedures.	The CODA Air Purification System will be used as
an accessory during assisted reproductive
procedures.
Target Population	Embryologists in IVF and ART Laboratories	Embryologists in IVF and ART Laboratories
	Device Characteristics and Design Features
Gas Line	Includes ¼" male and female quick disconnect	Includes ¼" male and female quick disconnect
Connection
Features	features on proximal and distal end of capsule.	features on proximal and distal end of capsule.
Installation	Filter placement between supply gas and
incubator using supplied standard ¼" male and
female quick connect fittings and holding bracket.	Filter placement between supply gas and
incubator using supplied standard ¼" male and
female quick connect fittings and holding bracket.
"Use Life" -
Frequency of
filter change	Up to 6 months	2 months
Shelf Life	3 years	No Information Available
Filtration
Efficiency	HEPA filter must capture a minimum of 99.97% of
particulate contaminants at 0.3 microns in size.

Actual Efficiency - The Origio Filter meets
requirements for both ULPA (Ultra Low
Penetration Air) and HEPA (High Efficiency
Particulate Air) with $\geq$ 99.999% efficiency for
particle sizes between 0.1-0.2 microns and 0.2-0.3
microns throughout the 3 year shelf life.

Use Life of up to 6 months was demonstrated
with filtration efficiencies meeting both ULPA and
HEPA requirements for filters challenged with a
worse case particle load simulating 6 months of
usage in an IVF Lab. | HEPA filter must capture a minimum of 99.97% of
particulate contaminants at 0.3 microns in size.

Comparison of Key Design Features and Characteristics

Origio Gas Line Filter - Traditional 510(K)

3

:

ouldlo

:

4

Performance Testing and Safety

Performance testing was conducted on the Origio Gas Line Filter demonstrating the overall structural integrity, filtration efficiency and the effectiveness in the reduction/removal of Volatile Organic Compounds. Structural integrity testing included the following: Flow Rate and Pressure Drop, Diffusion and Bubble Point and Burst Pressure.

Particle filtration efficiency testing was conducted using an industry standard test method to demonstrate the filters met HEPA and ULPA requirements. Particle filtration efficiency was conducted with new filters, aged filters and filters that were challenged with a simulated particle load representing 6 months of use life based upon reported "source air" particle levels found in typical IVF Laboratories.

VOC removal efficiency testing was performed using a challenge supply gas concentration containing 17 different VOCs based upon the published literature for the reported VOC levels found in the typical IVF Laboratory. VOC removal efficiency values for the Origio Gas Line Filter was demonstrated up to the 6-month use life for new and aged filters. Additional VOC efficiency testing was conducted confirming that filters which had already been in service in IVF laboratories for 6 months were still effective in removing VOC's at the end of their actual "Use Life".

Mouse Embryo Assay testing of the Origio Gas Line Filter was conducted with the Origio Gas Line Filter installed on the incubator gas supply line to provide verification that the use of Origio Gas Line Filter does not negatively impact or effect mouse embryo development.

Conclusion

Based on our performance testing and the assessment of the similarities and differences between the Origio Gas Line Filter and the predicate Coda Inline Filter, Origio believes the Origio Gas Line Filter is substantially equivalent with respect to the fundamental scientific technology, materials of construction, design features, filtration efficiency, VOC removal capabilities and intended use as compared to the predicate device "Coda InLine Filter", that was previously cleared under K001486, CODA Air Purification System.

5

Image /page/5/Picture/0 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 a stylized design featuring three wavy lines that resemble a caduceus, a symbol often associated with healthcare.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2014

Origio, Inc. John Clay Director of Regulatory Affairs 2400 Hunters Way Charlottesville, VA 22911

K132870 Re:

Trade/Device Name: ORIGIO® Gas Line Filter Regulation Number: 21 CFR§ 884.6120 Regulation Name: Assisted reproduction accessories Regulatory Class: II Product Code: MQG Dated: March 27, 2014 Received: March 31, 2014

Dear John Clay,

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.

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.

6

Page 2 - John Clay

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/CDRHOffices/ucm115809.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/7 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The text appears to be a signature or a title, with the "P." possibly indicating a middle initial.

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132870

Device Name ORIGIO® Gas Line Filter

Indications for Use (Describe)

The ORIGIO® Gas Line Filter is intended for the reduction of volatile organic compounds (VOC's) and particulate contaminants from supply gas lines to incubators and work stations that are used in assisted reproduction technologies and/or In vitro fertilization procedures.

Type of Use (Select one or both, as applicable)

2 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 FOR : :::

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Herbert P. Lerner -S
2014.05.07 13:34:25 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Explration Date: January 31, 2017 See PRA Statement below.