(210 days)
Not Found
No
The device description and performance studies focus on the mechanical design and function of a physical speculum, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to dilate the vagina and expose anatomical structures for examination, which is a diagnostic or procedural aid, not a treatment for a disease or condition.
No
A diagnostic device identifies a medical condition, disease, or risk factor. This device is used for exposure during examinations and procedures and does not diagnose a condition.
No
The device description clearly states it is a physical, disposable vaginal speculum made of polystyrene and polyurethane, used to dilate the vagina. It is a hardware device.
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 exterior of the cervix during pelvic examinations and other gynecological procedures." This is a physical manipulation of the body for visualization and access, not a test performed on a sample taken from the body.
- Device Description: The description details a physical instrument used for examination. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (e.g., chemical analysis, biological assay).
- Providing diagnostic information based on the analysis of a sample.
- Reagents, calibrators, or controls.
The device is a medical instrument used for a physical examination procedure.
N/A
Intended Use / Indications for Use
The ClearSpec® Single-Use 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.
Product codes
HIB
Device Description
The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.
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)
Bench testing has been conducted using simulated actual use conditions comparing the new device with the addition of the sheath to that of original speculum without the sheath. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included sheath material ability to survive stresses encountered during use without failure and sufficiency of sheath to speculum bond strength such that the sheath does not detach from the speculum during insertion, during the examination, or during withdrawal.
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
ClearSpec LLC 510(k) Notification Submission
510(k) Summary
Date: July 23, 2013
| Submitted by: | ClearSpec LLC
131 NW 13th Street, Suite 38
Boca Raton, FL 33432 | | |
|-------------------------|----------------------------------------------------------------------------------------------------------------|--|--------------|
| Phone:
Fax: | 561-395-7767
561-237-5040 | | |
| Contact: | Navroze Mehta | | |
| Common Name: | Vaginal Speculum | | |
| Trade Name: | ClearSpec® Single-Use Vaginal Speculum | | AUG 0 6 2013 |
| Classification
Name: | Speculum, Vaginal, Nonmetal | | |
| Classification: | Class II per 21 CFR 884.4530, Product Code: HIB | | |
| Predicate Device: | Gongdong Disposable Vaginal Speculum (K050887)
Welch Allyn KleenSpec® Single Use Vaginal Speculum (K120743) | | |
Device Description:
The ClearSpec Single Use Vaginal Speculum is a disposable vaginal speculum constructed of polystyrene, used to dilate the vagina and expose the interior of the vagina and exterior of the cervix, and employs a unique flexible polyurethane sheath that is designed to assist in keeping the lateral walls of the vagina clear of the viewing area. The vaginal speculum can be used with or without an illuminator. The ClearSpec® Single Use Vaginal Speculum is made available in various sizes from extra small to large to accommodate vagina cavity size.
Indications for Use:
The ClearSpec" Single-Use 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.
Technological Characteristics:
The subject device has the same technological characteristics and indications for use as the predicate Gongdong Disposable Vaginal Speculum and Welch Allyn KleenSpec® Single Use Vaqinal Speculum. The addition of a sheath surrounding the device blades to aid in retaining lateral vaginal tissue does not introduce any new concerns regarding safety or effectiveness. The designs have been demonstrated as substantial equivalent using bench testing.
1
The ClearSpec Single-Use Vaginal Speculum and identified predicate devices are constructed of similar material commonly used throughout the medical device industry for like and similar devices and have been tested for biocompatibility per FDA GPM G95-1 and ISO 10993-1 requirements for limited contact duration, surface contacting mucousal membrane device and found to be suitable for the intended use of this product.
Intended Use:
The ClearSpec® Single-Use 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 avnecological procedures.
Testing:
Bench testing has been conducted using simulated actual use conditions comparing the new device with the addition of the sheath to that of original speculum without the sheath. The results of the testing show the new device to perform as intended and equivalent to the predicate device. Testing included sheath material ability to survive stresses encountered during use without failure and sufficiency of sheath to speculum bond strength such that the sheath does not detach from the speculum during insertion, during the examination, or during withdrawal.
Conclusion:
In accordance with the Food, Drug, and Cosmetic Act and 21 CFR 807, and based on the information provided in the premarket notification, ClearSpec LLC concludes that the ClearSpec Single-Use Vaginal Speculum is substantially equivalent to the predicate device in terms of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 6, 2013
ClearSpec. LLC % Ira Duesler Consultant 603 Grant Street Herkimer. NY 13350
Re: K130046
Trade/Device Name: ClearSpec® Single-Use Vaginal Speculum Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: HIB Dated: July 8, 2013 Received: July 9, 2013
Dear Ira Duesler,
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 - Ira Duesler
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Glenn B. Bell -S
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: K130046
ClearSpec® Single-Use Vaginal Speculum Device Name:
Indications For Use:
The ClearSpec Single-Use 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.
Prescription Device _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/10 description: The image shows the name "Glenn B. Bell -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be a title or heading. The letters are bold and easily readable, with consistent spacing between them.
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130046 510(k) Number _