K Number

Device Name

HEAL FORCE CO2 INCUBATOR

Manufacturer

SHANGHAI LISHEN SCIENTIFIC EQUIPMENT CO., LTD

Date Cleared

2011-02-08

(209 days)

Product Code

MQG

Regulation Number

884.6120

Intended 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 Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K002805, K023465

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard incubator functionalities like temperature, CO2, humidity control, and disinfection, with no mention of AI or ML.

Therapeutic

No
This device is an incubator for developing ova or embryos, which falls under laboratory equipment for assisted reproduction, not a device used for treating a disease or medical condition in a living being.

Diagnostic

The device is an incubator designed to provide a controlled environment for the development of ova or embryos. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components like outer casing, inner casing, control elements, shelves, and heating cables, indicating it is a hardware device with integrated controls.

IVD (In Vitro Diagnostic)

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 a controlled environment for the development of ova or embryos. This is a laboratory process related to assisted reproduction, not a diagnostic test performed in vitro on a specimen to provide information about a patient's health.
Device Description: The description details the physical structure and heating system of an incubator, which is a piece of laboratory equipment used for maintaining specific environmental conditions. It does not describe a device that analyzes biological samples.
Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
Intended User/Care Setting: The intended user is an "assisted reproductive laboratory," which aligns with the use of an incubator for embryo development, not diagnostic testing.

IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) outside of the body to diagnose, monitor, or screen for diseases or conditions. This incubator's function is to support biological processes, not to perform diagnostic tests.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

MQG

Device Description

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.

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

Not Found

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)

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.

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.

K002805, K023465

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

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

Company and Correspondent making the submission:

Name - Shanghai Lishen Scientific Equipment Co., Ltd. Address - No.6788 SongZe Avenue, QingPu, Shanghai, China Telephone – +86-21-649-53016 Fax - +86-21-64953025, 64953071 Contact - Mr. Ma Ying Email – suhong@shanghai-lishen.com

2. Device :

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

Classification Name : Accessory, Assisted Reproduction

| Predicate

Model	Manufacturer	K Number
Kendro
Heracell
CO2
Incubator-
HERAcell	FORMA
SCIENTIFIC, INC	K002805	HF90
Kendro
Heracell
CO2
Incubator-
HERAcell	FORMA
SCIENTIFIC, INC	K023465	HF240

Predicate Devices

1. Classifications Names & Citations :
  21CFR 884.6120, MQG, CO2 Incubator, Class II
1. 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.

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.

Comparison with predicate device :

| Predicate

Model	Manufacturer	K Number
Kendro
Heracell
CO2
Incubator-
HERAcell	FORMA
SCIENTIFIC, INC	K002805	HF90
Kendro
Heracell
CO2
Incubator-
HERAcell	FORMA
SCIENTIFIC, INC	K023465	HF240

omparison Table 01 for Model HF90, HF240

| Element of

comparison	Subject Device	Claimed SE Device
Company	Shanghai Lishen Scientific Equipment Co., Ltd	Kendro Laboratory Products, L.P.
FDA510(K)
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
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.	The intended use of this incubator is to provide an
environment with controlled temperature; CO2 elevated
humidity, and an automatic decontamination mode, for
the development of ova or embryos at or near body
temperature.

17 of 336

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)
Power requirements	AC 230V
AC 120V	AC 230V
AC 120V	Relative Humidity	Constant humidity at 37°C
high-humidity mode: Approx. 95% rH
low-humidity mode: Approx. 90% rH		Constant humidity at 37°C
high-humidity mode: Approx. 95% rH
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
HF 240	650W
710W	HERAcell 150
HERAcell 240	640W
640W
	Temperature:	Temperature:
	Range
Ambient Temperature +3°C-+55°C
Time deviation $\pm$ 0.1 °C
spatial deviation $\pm$ 0.5 °C
Recovery time(at 37°C) ≤10min
(30 sec. door open, to 98% of initial value)	Range
Ambient Temperature +3°C-+55°C
Time deviation $\pm$ 0.1 °C
spatial deviation $\pm$ 0.5 °C
Recovery time(at 37°C) ≤10min
(30 sec. door open, to 98% of initial value)
Specification:	CO2 control
Set range 0-20%
Control accuracy $\pm$ 0.1%
Recovery time(5%CO2) ≤5min (HF90)	CO2 control
Set range 0-20%
Control accuracy $\pm$ 0.1%
Recovery time(5%CO2) ≤5min (HERAcell 150)

. .

19 of 336

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.

1. 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

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

Page 2

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 (800) 638-2041 or (301) 796-7100 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

Indications for Use

510(k) Number (if known): K101988

Device Name: HEAL FORCE CO2 Incubator

Indications For Use:

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