(11 days)
Not Found
No
The device description and intended use focus on a physical medical device (vaginal speculum and illuminator) and do not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are bench tests, not studies involving data analysis or model training.
No
The device is used to dilate the vagina and provide illumination for examination and procedures, but it does not treat medical conditions.
No
The device is used to dilate the vagina and illuminate the area for examination, not to diagnose a condition.
No
The device description clearly states it is a vaginal speculum and an illuminator, which are physical hardware devices used for medical procedures. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to physically dilate the vagina and expose the interior for visual examination and procedures. This is a mechanical function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical characteristics, materials, and biocompatibility of the speculum and illuminator. There is no mention of analyzing biological samples or performing any kind of diagnostic test.
- Lack of IVD Keywords: The text does not contain keywords typically associated with IVDs, such as "in vitro," "sample," "assay," "reagent," "analyte," "diagnosis," or "testing of biological specimens."
- Clinical Performance Data: The text explicitly states that "No clinical studies were necessary or utilized for the purpose of obtaining safety or effectiveness data." This is consistent with a physical device used for examination and procedure support, not a diagnostic test that would require clinical validation of its diagnostic accuracy.
The device is a medical instrument used to facilitate visual examination and procedures, not to perform a diagnostic test on a biological sample.
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 subject device has the same technological characteristics and indications for use as the predicate KleenSpec® Single Use Vaginal Speculum. The addition of the extra small size vaginal speculum does not introduce any new concerns regarding safety or efficacy. The designs have been demonstrated as substantial equivalent using bench test data.
Both the new size and the previously cleared KleenSpec® Single Use Vaginal Speculums are made of the same materials, which have biocompatibility testing according to FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device and are demonstrated to be suitable for the intended use of this product.
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
physician or licensed health care professional.
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)
No clinical studies were necessary or utilized for the purpose of obtaining safety or effectiveness data.
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
Image /page/0/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is simple and recognizable.
K120743
Pg 1 of 2
510(k) Summary
[As described in 21 CFR 807.92]
MAR 2 3 2012
Submitted by: Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
Contact Person: Kevin Crossen, Director Regulatory Affairs Phone: (315) 685-2609 Fax: (315) 685-2532 E-mail: Kevin.Crossen@welchallyn.com
Date Prepared: February 23, 2012
Trade Name: KleenSpec® Single Use Vaginal Speculum
Device Classification Name: Speculum, Vaginal, Nonmetal
Device Classification: Class II
Classification Reference: 884.4530
Classification Product Code: HIB
Predicate Devices: KleenSpec® Single Use Vaginal Speculum and 790 series Cordless Illumination System 510(k) Number K070964
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.
1
WelchAllyn
K120743
Pg. 2 of 2
The illuminator can be used independent of the speculum as a general-purpose light source.
This product is available for sale only upon the order of a physician or licensed health care professional.
Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate KleenSpec® Single Use Vaginal Speculum. The addition of the extra small size vaginal speculum does not introduce any new concerns regarding safety or efficacy. The designs have been demonstrated as substantial equivalent using bench test data.
Both the new size and the previously cleared KleenSpec® Single Use Vaginal Speculums are made of the same materials, which have biocompatibility testing according to FDA Blue Book Memo, G95-1, Use of International Standard ISO-10993 requirements for limited contact duration, surface contacting, mucosal membrane device and are demonstrated to be suitable for the intended use of this product.
Non-Clinical Tests:
Verification and validation tests were conducted in accordance with Welch Allyn design control procedure. They are tested using established testing procedures to ensure the products performance parameters conform to the product design specifications.
The following standards were applied to the modified device.
| Standard
| Identification Number | Title |
|---|---|
| ISO 14971 | Medical Devices – Application of Risk management to Medical Devices |
Clinical Performance Data:
No clinical studies were necessary or utilized for the purpose of obtaining safety or effectiveness data.
Conclusion:
Based on the information presented in this 510(k) premarket notification, Welch Allyn's KleenSpec® Single Use Vaginal Speculum modified to introduce a smaller size is considered substantially equivalent (as safe, as effective and performs as well as) to the currently marketed KleenSpec® Single Use Vaginal Specula.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Kevin Crossen Director, Regulatory Affairs Welch Allyn, Inc. 4341 State Street Road SKANEATELES FALLS NY 13153
MAR 2 3 2012
Re: K120743
Trade/Device Name: KleenSpec® Single Use Vaginal Speculum Regulation Number: 21 CFR& 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: March 8, 2012 Received: March 12, 2012
Dear Mr. Crossen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical
3
Page 2 -
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin K. Tweto
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications For Use
510(k) Number (if known): K | 20 743
Device Name: KleenSpec® Single Use Vaginal Speculum
KleenSpec® Single Use Vaginal Speculum 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)
Gastro-Renal, and