HEAL FORCE CO2 INCUBATOR

K101988 · Shanghai Lishen Scientific Equipment Co., Ltd. · MQG · Feb 8, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K101988
• Device Name: HEAL FORCE CO2 INCUBATOR
• Applicant: Shanghai Lishen Scientific Equipment Co., Ltd.
• Product Code: MQG · Obstetrics/Gynecology
• Decision Date: Feb 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.6120
• Device Class: Class 2

Indications for Use

For Models HF90, HF240, the intended use of these incubators is to provide an environment with controlled temperature, CO2 elevated humidity, and an automatic disinfection mode, for the development of ova or embryos at or near body temperature.

Device Story

Heal Force CO2 Incubator (Models HF90, HF240) provides controlled environment for ova/embryo development. Device features stainless steel inner casing; large-surface heating cables on exterior of inner casing; air jacket temperature control. Operates by maintaining precise temperature, CO2 levels, and humidity. Includes automatic disinfection mode (humid heat at 90°C). Microprocessor-controlled parameters and alarms. Used in assisted reproductive laboratories. Clinicians monitor culture conditions via digital controller. Benefits include consistent physiological simulation for embryo viability.

Clinical Evidence

Bench testing only. Performance validated through electrical, mechanical, and environmental safety testing per EN/IEC 60601-1-2 (EMC) and EN/IEC 61010. Comparative bench data provided for temperature control, CO2 recovery times, and humidity levels against predicate devices.

Technological Characteristics

Benchtop/floor-standing CO2 incubator. Materials: electrolytically galvanized steel (outer), stainless steel (inner). Heating: large-surface cables on inner casing exterior. Control: independent digital controller, microprocessor-based. Connectivity: standalone. Sterilization: 90°C humid heat automatic disinfection mode. Standards: EN/IEC 60601-1-2, EN/IEC 61010.

Indications for Use

Indicated for the development of ova or embryos at or near body temperature in a laboratory setting.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Kendro Heracell CO2 Incubator-HERAcell (K002805)
• Kendro Heracell CO2 Incubator-HERAcell (K023465)

Submission Summary (Full Text)

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101988

FEB - 8 2011

## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: March 30, 2009

1. Company and Correspondent making the submission:

Name - Shanghai Lishen Scientific Equipment Co., Ltd. Address - No.6788 SongZe Avenue, QingPu, Shanghai, China Telephone – [phone] Fax - [phone], 64953071 Contact - Mr. Ma Ying Email – [e-mail]

## 2. Device :

Trade/proprietary name: Heal Force CO2 Incubator, Models HF90 and HF240 : CO2 Incubator Common Name

Classification Name : Accessory, Assisted Reproduction

| Predicate<br>Model | Manufacturer | K Number | Submitted Device |
|-----------------------------------------------------|--------------------------|----------|------------------|
| Kendro<br>Heracell<br>CO2<br>Incubator-<br>HERAcell | FORMA<br>SCIENTIFIC, INC | K002805 | HF90 |
| Kendro<br>Heracell<br>CO2<br>Incubator-<br>HERAcell | FORMA<br>SCIENTIFIC, INC | K023465 | HF240 |

Predicate Devices

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- 3. Classifications Names & Citations :
21CFR 884.6120, MQG, CO2 Incubator, Class II

- 4. Description :
- 4.1 General

The HEAL FORCE CO2 Incubator is a piece of assisted reproductive laboratory equipment used for incubation of ova and embryos.

### Structure

- The outer casing is made of electrolytically galvanized steel sheet and . lacquered white (RAL 9002) .
- . The control elements are made of plastic.
- . The inner casing is made of stainless steel.
- Internal Fittings:
- The pullout shelves are tilt-proof and adjustable over a height of 50 mm. . Removal of shelves, carrier requires no tools, and they can be taken out together at a time.
- · Heating System:
- · Large-surface heating cables are arranged on the outside of the inner casing, to heat the interior space. The heating cables are placed beneath the water reservoir, on the ceiling, on the upper part of the rear wall and in front of the outer door.
- · When the outer door is heated, condensation will not precipitate on the glass door. Therefore, the interior remains clearly visible in spite of the prevailing high humidity. Condensation may be formed if the outer door is left open for some time.

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5. Indication for use : For Models HF90, HF240:

The intended use of these incubators is to provide an environment with controlled temperature, CO2 elevated humidity, and an automatic disinfection mode, for the development of ova or embryos at or near body temperature.

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6. Comparison with predicate device :

| Predicate<br>Model | Manufacturer | K Number | Submitted Device |
|-----------------------------------------------------|--------------------------|----------|------------------|
| Kendro<br>Heracell<br>CO2<br>Incubator-<br>HERAcell | FORMA<br>SCIENTIFIC, INC | K002805 | HF90 |
| Kendro<br>Heracell<br>CO2<br>Incubator-<br>HERAcell | FORMA<br>SCIENTIFIC, INC | K023465 | HF240 |

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omparison Table 01 for Model HF90, HF240

| Element of<br>comparison | Subject Device | Claimed SE Device |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Shanghai Lishen Scientific Equipment Co., Ltd | Kendro Laboratory Products, L.P. |
| FDA510(K)<br>Number | N/A | K002805 |
| Device Name | HEAL FORCE CO2 incubator | HERAcell CO2 Incubator |
| Model Number | HF90, HF240 | HERAcell 150, HERAcell 240 |
| Intended use(s) | For Models HF90 and HF 240, the intended use of these<br>incubators is to provide an environment with controlled<br>temperature, CO2, elevated humidity, and an automatic<br>disinfection mode, for the development of ova or<br>embryos at or near body temperature. | The intended use of this incubator is to provide an<br>environment with controlled temperature; CO2 elevated<br>humidity, and an automatic decontamination mode, for<br>the development of ova or embryos at or near body<br>temperature. |

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| Labeling | The HEAL FORCE incubators are bench top or floor standing units. They control CO2 (T/C), temperature (by independent digital controller with a separate switching device), provide elevated humidity, and feature a decontamination mode (Same as HERAcell Contracon automatic disinfection routine) incorporating humid heat at 90°C, Consistent culture conditions throughout the interior are achieved by the air jacket temperature control and exact simulation of physiological conditions. Controlled parameters and alarm functions are microprocessor controlled. | The HERAcell CO2 incubators are bench top or floor standing units. They control CO2 (T/C), temperature (by independent digital controller with a separate switching device), provide elevated humidity, and feature a decontamination mode (Contracon automatic disinfection routine) incorporating humid heat at 90°C. Consistent culture conditions throughout the interior are achieved by the air jacket temperature control and exact simulation of physiological conditions. Controlled parameters and alarm functions are microprocessor controlled. | | Recovery time(5%CO2) | ≤10min (HF240) | Recovery time(5%CO2) | ≤10min (HERAcell 240) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------------------------------------------------|-----------------------|
| Power requirements | AC 230V<br>AC 120V | AC 230V<br>AC 120V | Relative Humidity | Constant humidity at 37°C<br>high-humidity mode: Approx. 95% rH<br>low-humidity mode: Approx. 90% rH | | Constant humidity at 37°C<br>high-humidity mode: Approx. 95% rH<br>low-humidity mode: Approx. 90% rH | |
| Ambient temperature | +18 °C to + 33 °C | +18 °C to + 33 °C | Energy used and / or delivered (110/120V 50/60Hz) | HF 90<br>HF 240 | 650W<br>710W | HERAcell 150<br>HERAcell 240 | 640W<br>640W |
| | Temperature: | Temperature: | | | | | |
| | Range<br>Ambient Temperature +3°C-+55°C<br>Time deviation $\pm$ 0.1 °C<br>spatial deviation $\pm$ 0.5 °C<br>Recovery time(at 37°C) ≤10min<br>(30 sec. door open, to 98% of initial value) | Range<br>Ambient Temperature +3°C-+55°C<br>Time deviation $\pm$ 0.1 °C<br>spatial deviation $\pm$ 0.5 °C<br>Recovery time(at 37°C) ≤10min<br>(30 sec. door open, to 98% of initial value) | | | | | |
| Specification: | CO2 control<br>Set range 0-20%<br>Control accuracy $\pm$ 0.1%<br>Recovery time(5%CO2) ≤5min (HF90) | CO2 control<br>Set range 0-20%<br>Control accuracy $\pm$ 0.1%<br>Recovery time(5%CO2) ≤5min (HERAcell 150) | | | | | |

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7. Safety and Performance Data :

Electrical, mechanical, environmental safety and performance testing have been accomplished according to standard EN/IEC 60601-1-2 for EMC considerations and EN/IEC 61010 for product safety.

- 8. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shanghai Lishen Scientific Equipment Co., Ltd. concludes that HEAL FORCE CO2 Incubator, Models HF90 and HF240 is safe and effective and substantially equivalent to predicate devices as described herein.

END

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Shanghai Lishen Scientific Equipment Co., Ltd. c/o Mr. Charles Mack Principal Engineer International Regulatory Consultants, LLC 77325 Joyce Way ECHO OR 97826

# FEB - 8 231

Re: K101988

Trade Name: Heal Force CO2 Incubator (Models HF90 and HF240) Regulation Number: 21 CFR §884.6120 Regulation Name: Assisted reproductive accessories Regulatory Class: II Product code: MQG Dated: January 16, 2011 Received: January 31, 2011

Dear Mr. Mack:

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. 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 device-related

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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/CDRH/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lenoir MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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## Indications for Use

## Indications for Use

510(k) Number (if known): K101988

Device Name: HEAL FORCE CO2 Incubator

Indications For Use:

For Models HF90, HF240, the intended use of ; these incubators is to provide an environment with controlled temperature, CO2 elevated humidity, and and an automatic disinfection mode, for the development of ova or embryos at or near body temperature.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR AND/OR CON (Part 21 CFR 801 Subpart D)

Over-The-Counter Use ------------(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amm 722

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K101988