(60 days)
Not Found
No
The summary describes a simple, non-metal, hand-held vaginal speculum with no mention of AI, ML, image processing, or any computational capabilities.
No
The device is a vaginal speculum, used for exposure (diagnosis), not therapy.
No
The device is a vaginal speculum, which is used to expose the interior of the vagina, not to diagnose a condition. Its function is purely for exposure.
No
The device description clearly states it is a "non-metal (polystyrene), hand held device," indicating it is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body (in vitro).
- Device Function: The description clearly states the vaginal speculum is used to "expose the interior of the vagina." This is a physical tool used within the body for examination, not for testing specimens taken from the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the vaginal speculum is a medical device used for physical examination, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
Vaginal Speculums are single use and shall be used to expose the interior of the vagina.
Product codes (comma separated list FDA assigned to the subject device)
85 HIB
Device Description
The MAI vaginal speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 884.4530 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
| Section Seven: 510(k) Summary for Vaginal Speculums | |||||
|---|---|---|---|---|---|
| ------------------------------------------------------ | -- | -- | -- | -- | -- |
| Submitted by: | Medical Action Industries, Inc. (MAI)
25 Heywood Road
Arden, North Carolina 28704
Telephone: 828-681-8820 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Dennis Kanupp |
| Date Prepared: | September 4, 2002 |
| Proprietary Name: | Not Applicable |
| Common Name: | Disposable vaginal speculum |
| Classification Name: | Speculum, Vaginal, Non-metal |
| Predicate Device: | Leespec Disposable Vaginal Speculum |
Description of Device: The MAI vaginal speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
Intended use of the Device: To be used by medical professionals to expose the interior of the vagina to facilitate visualization during gynecological and obstetrical procedures.
Technical Characteristics: The MAI vaqinal speculum has the same technological characteristics as and is substantially equivalent to the Leespec Disposable Vaginal Speculum (K021017), manufactured by ITL Corporation.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HUMAN & HEALTH SERVICES" written around the edge. Inside the circle is a symbol that looks like three stylized human figures or faces stacked on top of each other. The logo is black and white and appears to be a scan or photocopy, as the image quality is somewhat degraded.
Public Health Service
NOV 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Action Industries, Inc. % Ms. Sharon Suess Graham Consultant Ryan Dietrich Engineering 2 Summit Drive ARDEN NC 28704
Re: K022948
Trade/Device Name: Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: September 4, 2002
Received: September 5, 2002
Dear Ms. Graham:
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, Drue, 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.
2
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,
Nancy C. Snigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Medical Action Industries, Inc · Vaginal Speculum 510(k) submission
vaginal speculum 510(k) submission
Section Six: Indications for Use Statement
510(k) Number: K 022948
Device Name: Vaginal Speculum
Indications for Use: Vaginal Speculums are single use and shall be used to expose the
interior of the vagina.
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V (Per 21 CFR 801.109)
OR
Over-The Counter Use _
David A. Wagner
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number