(227 days)
Not Found
No
The summary describes a standard optical colposcope for magnified viewing and image output, with no mention of AI, ML, image processing for analysis, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as a "Diagnostic Device" intended for "magnified viewing of the tissues of cervix" to "diagnose abnormalities and select areas for biopsy." It does not mention treating or curing any conditions.
Yes
The device is explicitly described as a "Diagnostic Device" in both the "Intended Use / Indications for Use" and "Device Description" sections, stating its purpose is to "diagnose abnormalities".
No
The device description explicitly states it consists of a "medical camera unit and accessories," a "main unit (power source)," and a "probe," all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The MEDISCOPE is described as a colposcope used for magnified viewing of the tissues of the cervix. It is a diagnostic device that allows doctors to visually inspect the cervix.
- No sample analysis: The description does not mention the device analyzing any samples taken from the patient. It is a direct visualization tool.
Therefore, the MEDISCOPE falls under the category of a medical device used for direct examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Gynecological and (Obstetrical colposcope MEDISCOPE, Diagnostic Device), is intended for magnified viewing of the tissues of cervix.
Product codes
85 HEX
Device Description
MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be used to magnify and view tissues of the cervix and diagnose abnormalities and select areas for biopsy. Mediscope consists of a main unit ( power source ) and probe.
MEDISCOPE is designed for effective communication and education between doctors and patients.
MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.
MEDISCOPE has undergone various electrical safety tests and has met the following standards.
-
- IEC 60601-1, Medical electrical equipment Part 1 : General requirements for safety.
-
- En 60601-1-2, Standard for Electromagnetic Compatiblity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1630 Colposcope.
(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
K03/436
1 of 2
SOMETECH CORPORATION 6669 PEACHTREE INDUSTRIAL BOULEVARD, SUITE J NORCROSS, GEORGIA 30092
TEL: 770-825-0100
FAX: 770-849-9733
SUMMARY OF SAFETY AND EFFECTIVENESS
APPLICANT'S NAME/ADDRESS
SOMETECH INC. JUNGIL B/D 6F 142-2 NONHYUN-DONG KANGNAM-GU SEOUL 135-010 SOUTH KOREA
CONTACT PERSON:
TRADE NAME:
COMMON/USUAL NAME:
CLASSIFICATION NAME:
OWNER OPERATOR #:
CLASSIFICATION:
PERFORMANCE STANDARD:
Mr. Ki Cheol Han
MEDISCOPE
COLPOSCOPE (AND COLPOMICROSCOPE)
COLPOSCOPE (AND COLPOMICROSCOPE)
9057673
CLASS II UNDER 21 CODE OF FEDERAL REGULATION 884.1630
MEDISCOPE MEETS ALL DESIGN SPECS AND IS EQUIVALENT TO THE PREDICATE DEVICE.
1
703.436
2082
SUBSTANTIAL EQUIVALENCE:
SOMETECH INC. BELIEVES THE MEDISCOPE IS SUBSTANTIALL Y EQUIVALENT TO THE WELCH ALLYN COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM ( 510 (K) NUMBER K955635 ).
MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be used to magnify and view tissues of the cervix and diagnose abnormalities and select areas for biopsy. Mediscope consists of a main unit ( power source ) and probe.
MEDISCOPE is designed for effective communication and education between doctors and patients.
MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.
MEDISCOPE has undergone various electrical safety tests and has met the following standards.
-
- IEC 60601-1, Medical electrical equipment Part 1 : General requirements for safety.
-
- En 60601-1-2, Standard for Electromagnetic Compatiblity.
In summary, MEDISCOPE meets or exceeds all safety requirements for a medical device in its class. Our dedication to safety is evidenced in the many steps we have taken to insure a safe product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that resemble a stylized human figure. The caduceus is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circular border.
DEC 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ki Cheol Han President Sometech Corporation 6669 Peachtree Industrial Blvd. Suite J NORCROSS GA 30092
Re: K031436
Trade/Device Name: MEDISCOPE Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: 85 HEX Dated: September 16, 2003 Received: September 22, 2003
Dear Mr. Han:
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 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); 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.
3
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 one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
Page 46
Indications for Use Statement
PMN 510(k) Number: KO3/436
MEDISCOPE Device Name:
(Colposcope (And colpomicroscope))
Indication for Use:
Gynecological and (Obstetrical colposcope MEDISCOPE, Diagnostic Device), is intended for magnified viewing of the tissues of cervix.
David C. Leyshon
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological De
510(k) Number
Prescription Use . ﺪ (Per 21 CFR 801.109)