(143 days)
No
The device description and intended use clearly describe a mechanical device (a speculum) used for physical examination. There is no mention of any software, image processing, or AI/ML terms.
No.
The device is used to dilate the vagina for visualization during examinations and procedures; it does not treat a disease or condition.
No
Explanation: The device is a speculum, which is an instrument used to expose the vagina and cervix for examination. It aids in visualization but does not inherently diagnose any conditions. Its purpose is to facilitate the examination, not to provide diagnostic information itself.
No
The device description clearly states it is a physical, disposable vaginal speculum made of plastic blades and a handle, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures." This describes a physical tool used for visualization and access during a medical procedure performed on the patient's body.
- Device Description: The description confirms it's a physical instrument ("plastic blades and handle") used by medical professionals to "visualize interior of vagina and cervix during patient examination."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not involve the analysis of any biological specimens.
Therefore, the IOB Disposable Speculum is a medical device used for physical examination, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.
Product codes
HIB
Device Description
The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.
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
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
Bench Testing and Stability Studies
Bench testing was performed by simulating actual usage comparing the device with the predicate speculum. The testing results show that the new device performs equivalent to the predicate device. Both bench testing and stability study show that the device is able to survive stresses encountered during use without failure.
Key Metrics
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
510(k) SUMMARY
| 1. Date: | January 9, 2014 | JAN 17 2014 | ||
|---|---|---|---|---|
| 2. Submitter: | IOB Medical Inc | |||
| 504E Diamond Ave., Suite F | ||||
| Gaithersburg, MD 20877 | ||||
| 3. Contact person: | Joe Shia | |||
| IOB Medical Inc. | ||||
| 504 East Diamond Ave., Suite F | ||||
| Gaithersburg, MD 20878 | ||||
| Telephone: 301-250-0831 | ||||
| Fax: 301-916-6213 | ||||
| Email:jshia@iobmedical.com |
-
- Device Name: IOB Disposable Speculum
-
- Classification:
ClassIl
| Product Code | CFR # | Panel |
|---|---|---|
| HIB | 21CFR 884-4530 Speculum Vaginal nonmetal | OBSTRETICS AND |
| GYNECOLOGY |
-
- Predicate Devices:
K091937
- Predicate Devices:
OBP Office-Spec Disposable Side Speculum
7. Intended Use
The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.
8. Device Description
The IOB disposable vaginal speculum consists of up and under plastic blades and handle with three different sizes (smail, medium and large). The speculum is used by medical professionals to visualize interior of vagina and cervix during patient examination.
-
- Technological Characteristics
The IOB disposable vaginal speculum has the same technological characteristics and indications for use as the predicate device. The new device is constructed using polystyrene that is commonly used by the medical device industry for like and similar devices. The device was tested for biocompatibility per FDA General Program Memorandum G95-1 and ISO 10993-1 requirements for limited contact duration, and was found to be compatible for the intended use of the product.
- Technological Characteristics
1
-
- Substantial Equivalence Information
A summary comparison of features of the 10B Disposable Speculum and the predicate devices is provided in Table 1
- Substantial Equivalence Information
Table 1: Features Comparison of the IOB Disposable Speculum and the Predicate Device
| Item | Device | Predicate - K091937 |
|---|---|---|
| Intended Use | For use on women undergoing a procedure | |
| requiring vaginal access and exposure. For | ||
| prescription use. | Same | |
| Material | PS | Same |
| Performance | Hand held and manually operated, | |
| multi-position, clear viewing | Same | |
| Configuration | Bi-valve plastic blades | Same |
| Usage | single use | Same |
| Sterility | Non-sterile | Same |
| Assembly | No assembly required | Same |
| Differences | ||
| Item | Device | Predicate - K091937 |
| Packaging | 20 small or medium size per pack | |
| 18 large size per pack | 18 small or medium | |
| size per pack | ||
| 16 large size per | ||
| pack |
- Safety and Performance Characteristics
-
- Biocompatibility testing (cytotoxicity, irritation and sensitivity) according to ISO 10993 for a limited contact device was demonstrated to be suitable for the intended use of the product.
-
- Bench Testing and Stability Studies
Bench testing was performed by simulating actual usage comparing the device with the predicate speculum. The testing results show that the new device performs equivalent to the predicate device. Both bench testing and stability study show that the device is able to survive stresses encountered during use without failure.
-
- Conclusion
Based on the information presented in this 510K premarket notification, the IOB Disposable Speculum is substantially equivalent to the predicate.
- Conclusion
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2014
IOB Medical, Inc. Joe Shia Regulatory Affairs 504 East Diamond Avenue, Suite F Gaithersburg, MD 20877
Re: K132668
Trade/Device Name: IOB Disposable Speculum Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: November 29, 2013 Received: December 4, 2013
Dear Joe Shia,
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.
3
Page 2 - Joe Shia
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 (reporting of medical 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,
Image /page/3/Picture/6 description: The image shows the name "Herbert P. Lerner -S" in a bold, sans-serif font. The text is black against a white background. There is some noise or artifacts around the letters, possibly from scanning or printing.
for
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
Indications for Use
510(k) Number: K132668
Device Name: IOB Disposable Speculum
Indications for Use:
The IOB Disposable Speculum is used to dilate the vagina and expose the interior of the vagina and the exterior of the cervix during pelvic examinations and other gynecologic procedures. It may be used with or without a removable light source.
Prescription Use __ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Herbert P. Lerner -S 2014.01.17 14:53:40 -05'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)_ ______________________________________________________________________________________________________________________________________________________________________