(43 days)
No
The device description and intended use are purely mechanical and illumination-based, with no mention of any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is used to dilate the vagina and expose the cervix for examination and procedures, but it does not directly treat a disease or condition. It is an examination and procedural tool, not a therapeutic agent.
No
The device is used to dilate the vagina and expose the cervix, and for illumination during procedures such as Pap smears and biopsies; it does not itself provide a diagnosis.
No
The device description clearly outlines physical components: a disposable vaginal speculum and a cordless illuminator. These are hardware devices used for physical procedures.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The KleenSpec® Single Use Vaginal Speculum and KleenSpec® 790 Series Cordless Illuminator are physical instruments used to facilitate visual examination and procedures within the vagina and cervix. They are used in vivo (within the living body) to provide access and illumination, not to analyze samples taken from the body.
- Intended Use: The intended use clearly states the devices are used to "dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures." This describes a physical manipulation and visualization process, not an in vitro diagnostic test.
Therefore, these devices fall under the category of medical devices used for examination and procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
KleenSpec® Single Use Vaginal Speculum: The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The vaginal speculum can be used with or without the illuminator. KleenSpec® 790 Series Cordless Illuminator: When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery. The illuminator can be used independent of the speculum as a general-purpose light source.
Product codes
HIB
Device Description
The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator. When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, 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
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
K070964 plot
WelchAllyn
Special 510(k) Premarket Notification KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System
14. Premarket Notification [510(k)] Summary
MAY 1 8 7007 Submitted By: Welch Allyn, Inc. 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220 Phone: (315) 685-4571 (315) 685- 2532 Fax: Contact: John E. Sawyer, Vice-President, Quality Assurance & Regulatory Affairs
-
Common Name: speculum, vaginal, nonmetal
Trade Name: KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System (Special 510(k)) -
Classification: 21 CFR § 884.4530; Class II
KleenSpec Disposable Vaginal Speculum 580 series (K941272) Predicate Device: -
Description: The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures such as: Pap smears, dilation and curettage (D&C), biopsy, & electrosurgery. Models with a smoke tube assembled to the upper blade can be connected to a separate smoke evacuator during electrosurgical procedures. The vaginal speculum can be used with or without the illuminator.
When used with the vaginal speculum, the cordless illurninator provides illumination during pelvic examinations. The illuminator can be used independent of the speculum as a general-purpose light source. -
Intended Use: KleenSpec® Single Use Vaginal Speculum
The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
The vaginal speculum can be used with or without the illuminator.
KleenSpec® 790 Series Cordless Illuminator
When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other
1
KC7Dx., 2 of 2
Velch Allyn
Special 510(k) Premarket Notification KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System
gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
The illuminator can be used independent of the speculum as a general-purpose light source. 。
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 1 8 2007
Chris Horacek VP and Associate General Counsel Welch Allyn, Inc. 4341 State Street Road SKANEATELES FALLS NY 13153-0220
Re: K070964
Trade/Device Name: KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System Regulation Number: 21 CFR §884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: April 4, 2007 Received: April 5, 2007
Dear Mr. Horacek:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo for the FDA Centennial, celebrating 1906-2006. The logo features the letters "FDA" in a bold, stylized font, with the word "Centennial" underneath. Three stars are arranged below the word "Centennial". The text "PROTECTING AND PROMOTING YOUR HEALTH" is arranged around the circle.
Protecting and Promoting Public Health
3
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
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
4
Welch Allyn
Special 510(k) Premarket Notification KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System
13. Statement of Indications For Use
| 510(k) Number (if known): | K070964 |
|---|---|
| Device Name: | KleenSpec® Single Use Vaginal Speculum and 790 series |
| Cordless Illumination System |
Indications For Use:
KleenSpec® Single Use Vaginal Speculum
The disposable vaginal speculum is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures.
The vaginal speculum can be used with or without the illuminator.
KleenSpec® 790 Series Cordless Illuminator
When used with the vaginal speculum, the cordless illuminator provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C), biopsy, and electrosurgery.
The illuminator can be used independent of the speculum as a general-purpose light source.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | Nancy C. Brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K070964 |
Section 13 – Page 1 of 1
MPD FCD-0026, Rev. 2
Section 13 Page I of I This document contains information considered to be CONFIDENTIAL to Welch Allyn, Inc.