BT-220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker. The fetal heart rate is measured using Doppler ultrasound.

Device Description

Bistos' BT-220L, BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being. BT-220 irradiates ultrasound wave to the abdomen of a pregnant women to detect. The Doppler frequency signal and analyze, displays the heart rate in LCD screen. The device also provides the heart sound from the heart of fetus.

AI/ML Overview

The provided document is a 510(k) summary for the Bistos Model BT-220L and BT-220C Ultrasonic Fetal Doppler. It primarily focuses on demonstrating substantial equivalence to a predicate device (BT-200T, K100885) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for the new device itself.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and expert involvement is not explicitly available in this document. The document refers to an "HR Accuracy Measuring Report (G)" which likely contains the performance data, but the report itself is not included in the provided text.

Based on the available information, here's what can be inferred and what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for the new device (BT-220L/220C). Instead, it relies on demonstrating substantial equivalence to the predicate device (BT-200T). It mentions an "HR Accuracy Measuring Report (G)," which implies that a study was conducted to measure heart rate (HR) accuracy. However, the specific metrics and acceptance thresholds from this report are not provided.

Inferred Acceptance Criterion (from substantial equivalence): The new device's HR accuracy is expected to be comparable to, or meet the performance of, the predicate device (BT-200T).

Acceptance Criteria (Inferred from Substantial Equivalence Goal)	Reported Device Performance (as implied by "HR Accuracy Measuring Report")
Heart Rate Accuracy similar to predicate device (BT-200T)	Performance data exists in "HR Accuracy Measuring Report (G)" (details not provided)

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the document. The "HR Accuracy Measuring Report (G)" would presumably contain these details.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. It's unclear if expert review was used or what their qualifications were.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC study comparing human readers with and without AI assistance is not applicable here as this device is a standalone fetal doppler, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance

Yes, a standalone performance assessment for the device (algorithm only, without human-in-the-loop performance) was performed. This is implied by the "HR Accuracy Measuring Report (G)" which assesses the device's ability to measure fetal heart rate. The device outputs a numerical heart rate on an LCD and audibly.

7. Type of Ground Truth Used

The document does not specify the exact type of ground truth used to establish HR accuracy. However, for a fetal heart rate monitor, the ground truth would typically be established by a reference standard measurement of fetal heart rate, possibly from a high-fidelity monitoring system or directly from a fetal electrocardiogram (ECG) if applicable, or by comparison to readings from a well-established and validated predicate device.

8. Sample Size for the Training Set

This information is not applicable/not provided. The BT-220L/220C is a traditional ultrasonic fetal doppler, not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on its hardware and signal processing algorithms, which are engineered rather than trained from data.

9. How Ground Truth for the Training Set Was Established

This information is not applicable/not provided due to the nature of the device (not an AI/ML system requiring a training set).

Summary

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

July 9, 2015

Bistos Co., Ltd % Young Chi President Bio-Med USA Inc. 27 New England Drive Ramsey, New Jersey 07446

Re: K142799

Trade/Device Name: Model BT-220L and BT-220C Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM Dated: June 2, 2015 Received: June 9, 2015

Dear Young Chi,

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 (reporting of medical device

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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 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" (21 CFR 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,

Benjamin R. Fisher -S

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

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Indications for Use

510(k) Number (if known) K142799

Device Name Ultrasonic Fetal Doppler Model BT-220L and BT-220C

Indications for Use (Describe)

BT-220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker.

The fetal heart rate is measured using Doppler ultrasound.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

As required by CFR 807.92(c)

1. Manufacturer

Prepared July 1, 2015

Bistos Co., Ltd. Reg Nr:3006179052 7th fl, A bldg WooLim Lions 3-cha 302 Galmachi ro, JungWon gu, Seoung Nam, GyungGi do, Rep of Korea Tel: 82 2 2108 4626 Fax : 82 2 2108 4629

2. Submitter, Contact person

Mr. Young Chi / President BioMed USA Inc. 27 New England Drive, Ramsey, NJ 07505. U.S.A. Tel: 973 278 5222 Fax: 201 934 6030 E mail: biomedusa@msn.com

3. Name of Device

Trade name :	Model BT-220L and BT-2200
Common or usual name :	Ultrasonic Fetal Doppler
Regulation number :	884.2660
Regulation class :	II
Product code :	HGM
Classification panel :	Obstetrics / Gynecology

4. Substantial Equivalence.

Bistos BT-220 Ultrasonic Fetal monitor is substantially equivalent in Intended use, Design, Function, Performance and all used material, direction to use, software, producing process, technology/principle of operation to already cleared BT-200T under 510(K)100885.

5. Indication for use.

The 220L/220C is a pocket sized ultrasonic fetal monitor that measures heart rate, which is displayed on an LCD display, and outputs fetal heart sounds through a built in speaker. the fetal heart rate is measured using Doppler Ultrasound.

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6. Device Description

Operating mode

Continuous Pulsed Doppler ●
. Fetal Movement

Detail, Engineering design. Performing features, Operating mode, attached

7. Biocompatibility test.

All used material of patient contacted part was done Biocompatibility test by NAMSA ( North American Science ) by FDA guidance Blue Book Memo G95-1 use of ISO 10993 Biological Evaluation of Medical Device part 4, 5, 10.

Body contacting classification: Surface device, skin, limited less than 24 hrs. The Skin contacting materials were found to be biocompatible.

Attached the Biocompatibility Certificate. (F)

8. Voluntary performed safety test result attached (B-E)

- HR Accuracy Measuring Report (G)
- Acoustic Output Test Report (F)
- CB Test Certificate (B, E)

9.Conclusion

Bistos' BT-220L/C Pocket size Fetal monitor in this submission is substantially equivalent to the already cleared BT-200T under K100885 at design, specification, intended use, used material, direction to use, software, Technology/principal operating and Performing etc in every angles.

The difference between the devices does not raise any new issues in safety or effectiveness End of summary

Regulation Number and Section

§ 884.2740 Perinatal monitoring system and accessories.

(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).