(114 days)
The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
i-scope 200 digital stethoscope is a new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope. It dose not cause pain to the ear despite long-term use due to newly introduced soft materials applied in earphone. i-scope 200 digital stethoscope is intended for medical diagnostic purposes only. It is used for the amplification of heart, lung and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any other use.
The provided document is a 510(k) summary for the i-Scope 200, a digital stethoscope. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance studies or specific acceptance criteria with quantifiable metrics. Therefore, much of the requested information cannot be extracted from this document, particularly regarding specific numerical performance, ground truth establishment, or multi-reader studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
Acceptance Criteria and Study Information for i-Scope 200:
-
Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific numerical performance metrics for the i-Scope 200. The claim for substantial equivalence is based on "same intended use and similar technological characteristics" to predicate devices, rather than meeting pre-defined quantitative performance thresholds. -
Sample Size used for the test set and the data provenance:
This information is not provided in the document. The traditional concept of a "test set" for performance evaluation, as would be used for AI/ML devices, is not discussed. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The concept of ground truth establishment by experts for a test set is not relevant to this type of 510(k) submission, which focuses on substantial equivalence to predicate devices. -
Adjudication method for the test set:
Not applicable; no specific test set or adjudication process is described. -
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. The i-Scope 200 is a digital stethoscope, a hardware device for amplifying body sounds. It is not an AI-assisted diagnostic software, and therefore, an MRMC comparative effectiveness study with or without AI assistance is not described or relevant in this context. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The i-Scope 200 is a standalone device in that it functions independently to amplify sounds, but it does not involve algorithms for automated diagnosis or a "human-in-the-loop" concept in the way AI/ML devices do. Its performance is based on sound amplification and filtering capabilities. -
The type of ground truth used:
Not applicable. The document does not describe a performance study that would require a ground truth for diagnostic accuracy. -
The sample size for the training set:
Not applicable. As this device is a hardware digital stethoscope and not an AI/ML algorithm requiring a training set, this information is not provided. -
How the ground truth for the training set was established:
Not applicable. No training set is described for this device.
Summary based on available information:
The K062364 submission for the i-Scope 200 is a traditional 510(k) notification focused on demonstrating substantial equivalence to existing legally marketed predicate devices (3M Littmann Electronic stethoscope, Model 4000 (K003723) and JABES electronic stethoscope (K031446)).
The primary "acceptance criterion," implicitly, is that the device shares the "same intended use and similar technological characteristics" as its predicates. This is the basis for the FDA's clearance. The document highlights:
- Intended Use: "amplification of heart, lung and other body sounds with selective frequency filtering" for "medical diagnostic purposes only" and "on any patient undergoing a physical assessment." This is stated to be the same as the predicate devices.
- Technological Characteristics: The i-Scope 200 is described as a "new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope" and uses "newly introduced soft materials applied in earphone" for comfort. These are presented as similar to, or improvements upon, the predicate technology, rather than requiring new performance thresholds.
The submission is notably devoid of specific performance data, clinical study results, or quantitative metrics. This is common for predicate-based 510(k) submissions of devices like stethoscopes, where equivalence in function and safety, without raising new questions of effectiveness, is the core of the review.
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DEC - 6 2006 510(k) SUMMARY
Submission Information US Agent: Chong Kim 32936 Bluebird Loop Fremont, CA 94555 Official Correspondent: Min-Kang Kim 513-14, Sangdaewon-Dong, #1022 Sicox Tower, Chungwon-Ku, Sungnam-Si, Kyunggi-Do, Republic of Korea Sponsor: Dongjin Medical Co., Ltd. #1022 Sicox Tower, 513-14, Sangdaewon-Dong, Chungwon-Ku, Sungnam-Si, Kyunggi-Do, Republic of Korea Manufacturing Site Dongjin Medical Co., Ltd. 513-14, #1022 Sicox Tower, Sangdaewon-Dong, Chungwon-Ku, Sungnam-Si, Kyunggi-Do, Republic of Korea Device Identification Trade Name: i-Scope 200 Common Name: Digital Stethoscope Stethoscope per 21 CFR § 870.1875 Classification Name: Product Code: DQD
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
The subject device, i-Scope 200, is substantially equivalent in technical
Substantially Equivalent Predicate Legally Marketed Devices
- characteristics and intended used to: 3M Littmann Electronic stethoscope, Model 4000(K003723) -
- JABES electronic stethoscope(K031446) -
Device Description
i-scope 200 digital stethoscope is a new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope. It dose not cause pain to the ear despite long-term use due to newly introduced soft materials applied in earphone. i-scope 200 digital stethoscope is intended for
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medical diagnostic purposes only. It is used for the amplification of heart, lung and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any other use.
Indications for Use
The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
Comparison to leally marketed predicate devices
The i-Scope has the same intended use and similar technological characteristics as the predicate devices. Thus, the i-Scope is substantially equivalent to the predicate devices.
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Public Health Service
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 2006
Dongjin Medical Co., Ltd. c/o Min-Kang Kim Manager #1022 Sicox Tower, 513-514 Sangdaewon-Dong, Chungwon-Ku Sungnam-Si, Kyunggi-Do REPUBLIC OF KOREA 462-806
Re: K062364
Trade Name: I-Scope 200 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: II (two) Product Code: DQD Dated: October 11, 2006 Received: October 11, 2006
Dear Mr. Kim:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Min-Kang Kim
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blumenthal for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
i-Scope 200
Indications for Use:
The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
B Zimmerman
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.