DFV CPG COLPOSCOPE

{0}------------------------------------------------ KD21854 OCT 2 5 2002 DFV-FDA CPG May 2002 #### 2.h. 510(k) Summary - 1) 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)<br>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<br>head | Electronic components, lamps, fiber optic cable | | Microscope head | Amplifies and illuminates the human body<br>region, which will be examined or<br>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)<br>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 _ ### Concurrence of CDRH, Office of Device Evaluation (ODE)