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.

Device Description

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. The device consists of Stands, Power supply, and Microscope head.

AI/ML Overview

The provided text is a 510(k) summary for the DFV CPG Colposcope from October 25, 2002. It describes the device and its intended use but does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in AI/ML performance evaluations.

This document is a traditional premarket notification for a medical device (a colposcope), not an AI/ML-driven device. Therefore, the questions related to AI/ML specific performance evaluation (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to existing colposcopes already cleared by the FDA, primarily by comparing physical and technical characteristics.

Here's the closest information available in the document, interpreted for a traditional medical device:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the way an AI/ML study would define performance metrics. Instead, it provides physical and optical specifications that are implicitly expected to meet industry standards for colposcopes and be comparable to predicate devices.

Specification	Reported Device Performance
Resolution (USAF 51 reticule)	Selector A: 20 line-pairs/mm
	Selector B: 28 line-pairs/mm
	Selector C: 45 line-pairs/mm
	Selector D: 56 line-pairs/mm
	Selector E: 72 line-pairs/mm
Depth of Field (USAF 51 reticule & comparator clock)	Selector A: ~15 mm
	Selector B: ~9 mm
	Selector C: ~3 mm
	Selector D: ~2 mm
	Selector E: ~1 mm
Distortion (%)	Ranges from approximately 0% to 10% (from graph)

Note: The document doesn't provide explicit acceptance criteria values (e.g., "resolution must be at least X line-pairs/mm"). The reported performance implicitly serves as proof that the device operates within acceptable parameters for a colposcope.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is not an AI/ML device and does not involve study on a 'test set' of patient data in this context. The performance metrics (resolution, depth of field) are measured using optical standards (USAF 51 reticule, comparator clock) on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth as typically understood for AI/ML is not relevant for this traditional device's performance claims.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/ML device.

5. 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. This is a traditional colposcope, not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. For resolution and depth of field, the "ground truth" is established by physical measurement standards (USAF 51 reticule, comparator clock).

8. The sample size for the training set:
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.

Summary

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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)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

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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 microscopehead	Electronic components, lamps, fiber optic cable
Microscope head	Amplifies and illuminates the human bodyregion, which will be examined orobserved 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

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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

6) Not applicable

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							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

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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.

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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

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2.g. Indications for use

510 (k) Number:

02185if

Device Name:

Colposcope

Indications for use:

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)

Regulation Number and Section

§ 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.