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.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (CO2 Incubator). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It is crucial to understand that a 510(k) submission for a non-AI/ML medical device like a CO2 incubator does not typically involve the kinds of studies or acceptance criteria that would be found for an AI/ML diagnostic or therapeutic device. The acceptance criteria are primarily focused on engineering and performance specifications, and the "study" is a comparison to a predicate device and adherence to recognized safety and performance standards for the incubator's function.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, training set ground truth) are not applicable to this type of device and submission.

Here's the information that is applicable based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are derived from the performance specifications of the predicate device, which the new device aims to match or demonstrate substantial equivalence to. "Reported device performance" refers to the specifications of the submitted device.

Element of Comparison	Predicate Device (HERAcell CO2 Incubator) Performance (Acceptance Criteria)	Submitted Device (HEAL FORCE CO2 Incubator) Performance
Temperature
Range	Ambient Temperature +3°C - +55°C	Ambient Temperature +3°C - +55°C
Time deviation	± 0.1 °C	± 0.1 °C
Spatial deviation	± 0.5 °C	± 0.5 °C
Recovery time (at 37°C)	≤10min (30 sec. door open, to 98% of initial value)	≤10min (30 sec. door open, to 98% of initial value)
CO2 Control
Set range	0-20%	0-20%
Control accuracy	± 0.1%	± 0.1%
Recovery time (5%CO2)	≤5min (HERAcell 150)	≤5min (HF90)
	≤10min (HERAcell 240)	≤10min (HF240)
Relative Humidity
Constant humidity at 37°C (high-humidity mode)	Approx. 95% rH	Approx. 95% rH
Constant humidity at 37°C (low-humidity mode)	Approx. 90% rH	Approx. 90% rH
Power requirements	AC 230V, AC 120V	AC 230V, AC 120V
Ambient temperature	+18 °C to + 33 °C	+18 °C to + 33 °C
Energy used	HERAcell 150: 640W, HERAcell 240: 640W	HF 90: 650W, HF 240: 710W

2. Sample size used for the test set and the data provenance

Not Applicable. This is an incubator, not an AI/ML diagnostic device that operates on a "test set" of data in the sense implied by the question. The "testing" involves engineering verification and validation of the physical device's performance against its specifications and relevant standards. The document doesn't provide details on the number of physical units tested or the data generated during performance verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. Ground truth in the context of an AI/ML device refers to a definitive correct answer for a diagnostic or classification task. For a CO2 incubator, the "ground truth" is adherence to physical/chemical parameters (temperature, CO2 concentration, humidity), which are measured by calibrated instruments, not established by human experts in this manner.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations for diagnostic tasks. This is not relevant to the performance verification of an incubator.

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 assess human performance (e.g., radiologists interpreting images) with and without AI assistance. This is entirely outside the scope of evaluating a CO2 incubator, which is a laboratory equipment device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device does not involve an algorithm with standalone performance in the sense of AI/ML. Its performance is measured as a fully contained physical system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the CO2 incubator is based on physical measurements using calibrated sensors and instrumentation to verify parameters such as temperature stability, CO2 concentration accuracy, humidity levels, and recovery times against established engineering specifications and product claims.

8. The sample size for the training set

Not Applicable. This device does not have a "training set" in the context of AI/ML algorithms.

9. How the ground truth for the training set was established

Not Applicable. Since there is no training set, there is no ground truth for a training set to be established.

Study that proves the device meets the acceptance criteria:

The document describes the following "study" and evidence of meeting acceptance criteria for substantial equivalence:

Comparison to Predicate Devices: The primary method for proving the device meets acceptance criteria and is safe and effective is a direct comparison table (Table 01 for Model HF90, HF240) against legally marketed predicate devices (Kendro Heracell CO2 Incubator - K002805 and K023465). The comparison demonstrates that the submitted device has identical or substantially similar technological characteristics and performance specifications for key parameters like temperature control, CO2 control, humidity, recovery times, and physical construction.
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." This indicates that the device underwent engineering verification and validation against recognized international standards to ensure its safety and performance. This is the "study" that supports the device specifications and, by extension, its substantial equivalence to predicate devices, thus meeting "acceptance criteria."

In summary, for a non-AI/ML medical device like a CO2 incubator, the "acceptance criteria" are its technical specifications matching those of a predicate device and adherence to general safety and performance standards. The "study" is the verification and validation testing against these standards and the demonstration of substantial equivalence through comparison with a predicate device.

Summary

{0}------------------------------------------------

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

PredicateModel	Manufacturer	K Number	Submitted Device
KendroHeracellCO2Incubator-HERAcell	FORMASCIENTIFIC, INC	K002805	HF90
KendroHeracellCO2Incubator-HERAcell	FORMASCIENTIFIC, INC	K023465	HF240

Predicate Devices

{1}------------------------------------------------

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.

{2}------------------------------------------------

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 :

PredicateModel	Manufacturer	K Number	Submitted Device
KendroHeracellCO2Incubator-HERAcell	FORMASCIENTIFIC, INC	K002805	HF90
KendroHeracellCO2Incubator-HERAcell	FORMASCIENTIFIC, INC	K023465	HF240

{3}------------------------------------------------

omparison Table 01 for Model HF90, HF240

Element ofcomparison	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 theseincubators is to provide an environment with controlledtemperature, CO2, elevated humidity, and an automaticdisinfection mode, for the development of ova orembryos at or near body temperature.	The intended use of this incubator is to provide anenvironment with controlled temperature; CO2 elevatedhumidity, and an automatic decontamination mode, forthe development of ova or embryos at or near bodytemperature.

17 of 336

{4}------------------------------------------------

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 230VAC 120V	AC 230VAC 120V	Relative Humidity	Constant humidity at 37°Chigh-humidity mode: Approx. 95% rHlow-humidity mode: Approx. 90% rH		Constant humidity at 37°Chigh-humidity mode: Approx. 95% rHlow-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 90HF 240	650W710W	HERAcell 150HERAcell 240	640W640W
	Temperature:	Temperature:
	RangeAmbient Temperature +3°C-+55°CTime deviation $\pm$ 0.1 °Cspatial deviation $\pm$ 0.5 °CRecovery time(at 37°C) ≤10min(30 sec. door open, to 98% of initial value)	RangeAmbient Temperature +3°C-+55°CTime deviation $\pm$ 0.1 °Cspatial deviation $\pm$ 0.5 °CRecovery time(at 37°C) ≤10min(30 sec. door open, to 98% of initial value)
Specification:	CO2 controlSet range 0-20%Control accuracy $\pm$ 0.1%Recovery time(5%CO2) ≤5min (HF90)	CO2 controlSet range 0-20%Control accuracy $\pm$ 0.1%Recovery time(5%CO2) ≤5min (HERAcell 150)

{5}------------------------------------------------

. .

19 of 336

{6}------------------------------------------------

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

{7}------------------------------------------------

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

{8}------------------------------------------------

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

{9}------------------------------------------------

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

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.