(141 days)
Not Found
No
The summary describes a standard optical colposcope and does not mention any AI or ML capabilities, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a diagnostic tool used for viewing and examining tissues for abnormalities, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix." This indicates its purpose is to aid in diagnosis.
No
The device description explicitly states that the device consists of "Stands, Power supply, and Microscope head," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Colposcope is used to view the tissues of the vagina and cervix directly on the patient's body using a telescopic system. It does not involve the analysis of samples like blood, urine, tissue biopsies, etc., which are typical for IVDs.
- The device description focuses on optical viewing. The components listed (Stands, Power supply, Microscope head) are consistent with a device used for direct visual examination, not for performing laboratory tests on specimens.
Therefore, the Colposcope described is a medical device used for direct visualization and examination of anatomical structures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix. The patient's population for which the Colposcope is intended is any person of the feminine sex.
Product codes
85 HEX
Device Description
The DFV CPG Colposcope consists of three main parts: Stands, Power supply, and Microscope head. The Stands support the microscope head and are made of brass, aluminum, plastic, and steel. The Power supply illuminates the microscope head and contains electronic components, lamps, and a fiber optic cable. The Microscope head amplifies and illuminates the human body region to be examined or observed by the physician and is made of brass, aluminum, steel, optical glass, and plastic.
Physical characteristics include a Galilean optical system, straight Porro type 160 mm binoculars, a 300 mm objective, and wide field type 12.5x adjustable eyepieces. It has an interpupillary distance of 55-75 mm and uses a 15V - 150W lamp for illumination. Macro focus is achieved with stand set movement, and micro focus is a gear rack and pinion manual. The head weight ranges from 3.8 kg to 6.0 kg, with a vertical stroke of 250 mm. The height between the floor and objective is 950 mm, and the stand set weight is 7 kg.
Resolution (reticule USAF 51) varies by selector position (A to E) with line-pairs/mm ranging from 20 to 72. Depth of field (reticule USAF 51 and comparator clock) also varies by selector position, ranging from approximately 1 mm to 15 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina and 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)
K000707, K981958, K963593, K955635, K940094, K932896, K884934, K871682, K853389, K852980, K770896, K770697, K761205, K760763
Reference Device(s)
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
§ 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
KD21854
OCT 2 5 2002
DFV-FDA CPG May 2002
2.h. 510(k) Summary
-
- Submitter's name: D.F.Vasconcellos S.A. Address: Avenida Indianópolis, 1706 - São Paulo - SP - Brasil Contact person: Gilberto Alves Barral Phone number: 11-55-11-5584 0411 E-mail: diretoria@dfv.com.br Date: 05/27/2002 2) Device's Name: DFV CPG Colposcope
- Proprietary Name: D.F.Vasconcellos S.A. Usual Name: Colposcope Classification Name: Colposcope
3) Devices substantially equivalent
There are many others devices already registered on FDA, substantially equivalent to Colposcope DFV, with the same physical and technical characteristics. The structure and material of devices are the same too. See the table above:
| Device Name | Applicant Name | 510(k)
Number |
|----------------------------------|----------------------------------|------------------|
| Leica Colposcope | Leica Microscopy Systems | K000707 |
| Leisegang Video Colposcope | Netoptix Corp. | K981958 |
| IMT Loupe-Colposcope | Inventive Medical Technol | K963593 |
| Video Colposcope/vertical | Welch Allyn, Inc. | K955635 |
| Colposcopes and accessories | Leisegang Medical, Inc. | K940094 |
| HM-0690 Colposcope | Hill-Med, Inc. | K932896 |
| Jedmed KP6 Colposcope | Jedmed Instrument Co. | K884934 |
| Wallach Convertible Colposcope | Wallach Surgical Devices | K871682 |
| Wallach Zoom Colposcope | Wallach Surgical Devices | K853389 |
| OCS-2 Colposcope | Olympus Corp. | K852980 |
| Colposcope Model II | Dynatech Cryomedical Co. | K770896 |
| Colposcope System | Richard Wolf Medical Instruments | K770697 |
| Dynatech JD7/JD7P Colposcope | Dynatech Cryomedical Co. | K761205 |
| Colposcope (Dynatech Colposcope) | Dynatech Cryomedical Co. | K760763 |
1
一
4) Description of the Device
| Part | Function | Design |
|---|---|---|
| Stands | Serves to support the microscope head | Brass, aluminum, plastic, steel |
| Power supply | Supplies illumination to the microscope | |
| head | Electronic components, lamps, fiber optic cable | |
| Microscope head | Amplifies and illuminates the human body | |
| region, which will be examined or | ||
| observed by the physician | Brass, aluminum, steel, optical glass, plastic |
Physical characteristics:
| Colposcope | Galilean system |
|---|---|
| Binoculars | Straight Porro type 160 mm |
| Objective | 300 mm |
| Eyepieces | Wide field type 12.5x adjustable |
| Magnifications | See table on page 9 |
| Observation field | See table on page 9 |
| Illuminated field | See table on page 9 |
| Interpupillary distance | 55-75 mm |
| Illumination field | Lamp 15V - 150W |
| Macro focus | With stand set movement |
| Micro focus | Gear rack and pinion manual |
| Head weight | 3.8 kg to 6.0 kg |
| Vertical stroke | 250 mm |
| Height between floor and objective | 950 mm |
| Stand set weight | 7 kg |
2
Resolution (reticule USAF 51):
| Selector position | A | B | C | D | E |
|---|---|---|---|---|---|
| Resolved block | 4-3 | 4-6 | 5-4 | 5-6 | 6-2 |
| Line-pairs/mm | 20 | 28 | 45 | 56 | 72 |
Depth of field (reticule USAF 51 and comparator clock):
| Selector position | A | B | C | D | E |
|---|---|---|---|---|---|
| Depth of field (mm) | ~15 | ~9 | ~3 | ~2 | ~1 |
Image /page/2/Figure/5 description: The image shows a graph titled "DISTORTION (%)". The y-axis ranges from -10 to 10, while the x-axis is not labeled. A curve starts near zero and gradually increases to a value near 10 as x increases.
5) Intended use of the device
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix. The patient's population for which the Colposcope is intended is any person of the feminine sex.
6) Not applicable
3
| 8 % % % % | ದರ | 19 | । ਹਵਾਲੇ ਇੱਕ | 89 | ਣ ਬ ਉਣ | ાં આવેલું એક ગામનાં લોકોનો | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 160 | ||||||||||||||||||||||
| field | 125 | 32 | 18 | ਡ ਡੇ | 32 | 18 | ତୀୟ ୨୦୧ | ស់នៃ ខេត្ត ខេត | ರ | |||||||||||||
| 400 | f160 | 0 0 4 2 0 | വ സ്വാധ ഈ | లు లు అల్లి ది | ||||||||||||||||||
| magnification | 125 | - u w w a u w a r 5 | ധ പ ര ര വ | ા છો | ||||||||||||||||||
| 1160 | ട് ഒട്ട് പ്രേ ശ | ਵਟ | gl | 90 | ន និង ខេ | 15 | ર્સ | ణ స | 13 | 8 | ||||||||||||
| field | f125 | รี รับ เ | 29 | 6 | 115 | 94 | LP | 29 | 6 l | દર્શા | ਕਤੇ | ਉਟ | 1 e | ﺎ ﺗﺎ | ||||||||
| 350 | 1160 | U W U F = | N 4 60 0 | র । | 4 0 0 0 0 0 0 | ങ്ങ | ||||||||||||||||
| magnification | 125 | N N 4 0 0 ( 1 0 0 0 0 0 0 0 0 0 0 | ಲ | 4 × 50 | ||||||||||||||||||
| 1160 | ର ସଙ୍ଗୀତ ୨୮ | ົວ ວັ | 81 | ୍ତ | ਟੂਰ | റി | દા | র ব | છે. ઉટ | ﺎ ﻟ | L | |||||||||||
| field | 125 | ට පිට | છે છે રે | 91 | 66 | ട്ട | Op | 25 | ા સ્ટ | ട്ട | ਨ ਦੇ ਹੋ ਪਵ | 6 Pr | ||||||||||
| 300 | 1160 | വസ്ത്രത്ത | ಒ | 4 ← | 17 | ਪ | r - | 17 | 27 | 75 | ||||||||||||
| magnification | 125 | น เมื่อ ปี พ.ศ. 2 | ਟ | സ് ഗ്രാമസ | സ് സ്ഥയു | 21 | ||||||||||||||||
| SE | 1160 | ട്ട | ਉਹ | 1 6 | 11 | ട്ട | রে | 91 95 | ﺎ ﻟﻠ | 37 | റ്റു ഗ്രാമ്പ്യ | |||||||||||
| LEN | field | f125 | ន ផ្លូវ និង និង | റ്റ് റ്റ് 62 | ਲ ਹੈ ਜ | 45 | 日 67 67 | ﻠ | ||||||||||||||
| BJECTIVE | 250 | 1160 | ಲ 4 ಒಂದಿ ಪ | ల గ్రామం గ్రా | 20 | ഗ ധ | 13 | ਟ ਦੇ ਇ | 62 | |||||||||||||
| magnification | ે જિહ | റ്റ് സ് ഗ്ര ഗ്ല | ్ర | ﮨﺎ ﮨ | ﺎ ﻟ | しい | ムレー | ムレ | ਉਣ | |||||||||||||
| f160 | ਨ ਦੇ ਇੱਕ | । ਟੁ | ସ ପ୍ର | ਟੈੱਡ | وي | દા | 8 | อ อย ซึ่ง หาร | ||||||||||||||
| field | f125 | દક | প্র | とし ここで | ﺎ ﻟ | દર્ભ | টি | 27 | ﺎ ﺗﺎ | 37 | 25 | ഗ്ഗം ഗു ത ശ | ||||||||||
| 200 | 1160 | లు అంది పై | 0ਟ | 4 @ 5 | 91 | SZ | ﺎ | 0 l | 1 은 | श्र दें दे | ട്രാ | |||||||||||
| magnification | 125 | ω 4 0 0 0 0 0 0 0 0 0 | ਨੇ | ഗ്രാമ്പ് സ്വീകരിച്ചു. അവലംബം പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവുമായി പ്രവും പ്രവുമാന്തിനും പ്രവുമാന്തിനും പ്രവുമാ | ਵਿੱਚ | |||||||||||||||||
| 160 | ਦੀ ਹੈ। ਉਸ | 18 | 11 | ﺴﺎ | । ਵੀ | 29 | 8 ↓ | 11 | L | ﺎﺕ ﻭﻕ | ০ ত ব | |||||||||||
| field | 125 | 58 | ಕ್ಕೆ | 24 | Si | 0 ﺗ | ട്ക | 38 | ਡ ਵ | ol Gi | 33 | പ്പോൾ ഗ്ല | ||||||||||
| f160 | 4 | 9 | ರಿ | 15 | 26 | S | 1 | 11 | 1 છ | 29 | L | 11 | 18 | 30 | 46 | |||||||
| nagnification | 125 | ల | 9 | 1 | ਟ | 17 | P | 9 | ರ | ടി | 23 | 9 | ರಿ | 14 | 23 | 35 | ||||||
| 1160 | 26 | 11 | 9 | 4 | 26 | 17 | 9 | 4 | ഹ | 0 | 9 | A | ਟ | |||||||||
| field | 125 | રૂટિ | 23 | 14 | ರಿ | 9 | રૂટ | 23 | 14 | 6 | 9 | 20 | 13 | 8 | ು | € | ||||||
| 1160 | 10 | 1 B | 26 | 40 | 8 | ાં રે | 20 | 33 | ടവ | 13 | 20 | ਟ ਦੇ | ਟ ਤ | 80 | 25 | |||||||
| agnificatio | 125 | S | L | ਟ | 1 ਤੇ | 29 | 0 | 10 | പു | 25 | ਤੰਬ | 10 | 15 | ਸਟ | ಕ್ಕೆ ಕ | 63 | ||||||
| POSITION | BUTTON | ക്ക് വിട്ടു ആവശ്യ വിവിച്ചു. വിവ്യക്ഷിക്കുന്നു. 1990 ലെ വിവ്യാവിയ 1990 ലെ വിള | 40 (2.5) | 6 (0.4) | 0 (0.6) | 16 (1.0) | 25 (1.6) | 40 (2.5) | ופי ה) נפוצות המופים של מורים (היסטורים של משום של שנו של שנו של שנו של שנו של שלים (מילים של מיני (מיני מושים של שנו של שנו של שלים) מילים שלום ליני (מילים שלום שלום (מילים | 25 (1.6) | ||||||||||||
| 40 (2.5) | ||||||||||||||||||||||
| LUMINATED FIE | ||||||||||||||||||||||
| EPIECI | 10X | 12.5X | 20X | |||||||||||||||||||
Iagnification Tabl
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font. The words are arranged on a single line, with 'Public' and 'Health' being slightly larger than 'Service'. The text is dark and contrasts with the background.
Food and Drug Administration 200 Corporate Boulevard ockville MD 20850
D.F. Vasconcellos S/A % Mr. Jean M. Buchwald Albee Import & Export of California 1990 NE 163rd Street, Suite 107 NORTH MIAMI BEACH FL 33162
Re: K021854
Trade/Device Name: DFV Colposcopes Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: 85 HEX Dated: September 4, 2002 Received: September 11, 2002
Dear Mr. Buchwald:
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.
Image /page/4/Picture/11 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. Inside the circle is a stylized image of an eagle's head with three curved lines extending from the back of the head. The logo is black and white.
5
This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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,
Henry C. Snigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
2.g. Indications for use
510 (k) Number:
02185if
Device Name:
Colposcope
Indications for use:
A Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix. The patient's population for which the Colposcope is intended is any person of the feminine sex.
Prescription Use
David A. Wegman
(Division Sign-Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _