(151 days)
Not Found
No
The 510(k) summary describes a purely mechanical device (vaginal speculum) and contains no mention of AI, ML, image processing, or any software-driven analytical capabilities.
No
The device is described as a non-sterile disposable vaginal speculum used for visualization during examination, not for treating a condition.
No
The device is described as a tool for visualization during examination, not for making a diagnosis. Its function is to allow a medical professional to see the vagina and cervix, which is part of an examination, but the speculum itself does not provide diagnostic information.
No
The device description clearly states it is a physical, disposable vaginal speculum made of up-foliage, under-foliage, and a handle, indicating 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 "visualize the interior of the vagina and cervix during obstetrical and gynecological examination." This is a direct examination of the patient's anatomy, not the analysis of a sample taken from the body.
- Device Description: The description details a physical instrument used for examination, not a reagent, kit, or instrument used to test a biological sample.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a tool for direct visual examination.
N/A
# Intended Use / Indications for Use
The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.
# Product codes (comma separated list FDA assigned to the subject device)
HIB
# Device Description
The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
Vaginal canal
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
medical professional / medical facilities or office/clinical examination rooms
# 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)
Mechanical, environmental safety and performance testing have been accomplished according to standards YY0336-2002, Disposable Vaginal Speculum; ISO 10993-5 , Biological Evaluation for Medical Devices, tests for Cytotoxicicy; ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hyper sensitivity.
# 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.
[K050887](https://510k.innolitics.com/search/K050887)
# 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
K092870
510(k) Summary
FEB 1 6 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: July 18, 2009
- Company and Correspondent making the submission:
Name - Kunshan Deyi Plastic Co., Ltd.
Address - No. 270, Zhongjie Road. Shipu Street,
Qiandeng Town, Kunshan City
Jiangsu Province China
Telephone -- +86-512-57408271
Fax -- +86-512-57408644
Contact – Mr. Alan Zhou
Email - jacky_chen@deyiplastic.com
- Device :
Trade/proprietary name: Disposable Vaginal Speculum
: Vaginal Speculum Common Name
Classification Name : speculum, vaginal, nonmetal
Predicate Device:
| Predicate
| Model | Manufacturer | K Number | Submitted Device |
|---|---|---|---|
| Non-sterile | |||
| DISPOSABLE | |||
| VAGINAL | |||
| SPECULUM | ZHEJIANG | ||
| GONGDONG | |||
| DEDICAL PLASTIC | |||
| FACTORY | K050887 | Non-sterile DISPOSABLE | |
| VAGINAL SPECULUM |
1
3. Classifications Names & Citations :
21CFR 884.4530, HIB, Speculum, Vaginal, Nonmetal
4. Product description :
The disposable vaginal speculum consists of up-foliage, under-foliage and handle with the specification of large, medium and small, which is used by medical department for examining female patients.
-
- List of sizes and specifications :
| Material | Model | Bottom
Diameter
(d: mm) | Mouth Diameter
(d: mm) | Height (H;MM) |
|----------|--------|-------------------------------|---------------------------|---------------|
| PS | Small | 90 | 30 | 90 |
| | Medium | 100 | 38 | 110 |
| | Large | 118 | 45 | 115 |
Image /page/1/Figure/6 description: The image shows a technical drawing of a medical device, possibly a speculum. The drawing includes two views of the device, a side view and a front view. The side view shows the device's overall shape and the adjustable components, labeled as 1 and 2. The front view provides a more detailed look at the device's structure and internal mechanisms.
ਸ਼ਹਿ
2
- Indication for use :
The disposable vaginal speculum is a non-sterile product and is to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.
- Comparison with predicate device : (see table next page)
3
Comparison Table
| Element of comparison | Subject Device | Claimed SE Device |
|---|---|---|
| Company | KUNSHAN DEYI PLASTIC CO., LTD. | ZHEJIANG GONGDONG DEDICAL PLASTIC FACTROY |
| FDA510(K) Number | N/A | K050887 |
| Device Name | Non-sterile DISPOSABLE VAGINAL | |
| SPECULUM | Non-sterile DISPOSABLE VAGINAL SPECULUM | |
| intended use(s) | Same | The Non-sterile DISPOSABLE VAGINAL SPECULUM is non-sterile products and |
| is intended to be used by a medical professional to expose the interior of the | ||
| vagina to facilitate visualization during the obstetrical and gynecological | ||
| procedures. | ||
| Production method | Same | injection molding |
| Material of construction | Same | Polyrex PG-33 |
| View | Same | Providing clear plastic for viewing |
| Lateral wall protector | Same | Rests in the lateral wall protector affording less chance of interfering with view |
| of the vagina during procedures | ||
| Hand operated, multi-position; | ||
| Performance | Same | Constructionally equivalent to the cooper speculum which has already been |
| subjected to millions of applications; | ||
| Hand held and manually operated? | Yes | Yes |
| Heat to escape | Same | Has windows/Vent that allow heat to escape |
| Assembly | Same | Doesn't require assembly |
| Hand held and manually operated? | Yes | Yes |
| Design | Same | Dual, biparting blades |
| Single Use? | Yes | Yes |
| Sterile status | Non-sterile | Non-sterile |
| Mechanical safety | Same | Simple thumb adjustable lever action |
| Lubrication | Same | Non-Lubricated |
| Packaging | Same | Bulk pack 10/Plastic Bag, and Individually wrapped |
| Biocompatibility | Same | Complying with ISO10993 |
| Anatomical sites | Same | Vaginal canal |
| Human Factors | Same | Single handed use, Self-locks in open position |
·
.
·
·
·
4
| Compatibility with the environment | Same | Disposable |
|---|---|---|
| Compatibility with the other devices | Same | Compatible with various spatula, Cyto brushes, packing forceps, sound and tenaculum, Tischler Bioposy forceps, scrapers, swabs and probes |
| Where used? | Same | By a physician; Professional medical facilities or office/clinical examination rooms |
·
.
. . . . .
.
5
-
- Safety and Performance Data :
Mechanical, environmental safety and performance testing have been accomplished according to standards YY0336-2002, Disposable Vaginal Speculum; ISO 10993-5 , Biological Evaluation for Medical Devices, tests for Cytotoxicicy; ISO 10993-10, Biological Evaluation for Medical Devices, tests for irritation and delayed type hyper sensitivity.
- Safety and Performance Data :
9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Kunshan Deyi Plastic Co., Ltd. concludes that the disposable vaginal speculum is safe and effective and substantially equivalent to predicate devices as described herein.
- Kunshan Deyi Plastic Co., Ltd. will update and include in a summary any other 10. information deemed seasonably necessary by the FDA.
END
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Kunshan Devi Plastic Co., Ltd. % Mr. Charles Mack, PE Principal Engineer International Regulatory Consultants 77325 Joyce Way ECHO OR 97826
FEB 1 6 2010
Re: K092870
Trade/Device Name: Disposable Vaginal Speculum Regulation Number: 21 CFR §884.4530 Regulation Name: Vaginal Speculum, non-metal Regulatory Class: II Product Code: HIB Dated: January 26, 2010 Received: February 1, 2010
Dear Mr. Mack:
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 Ameridments, 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 device-related
7
Page 2 -
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,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _ K 092870
Device Name: Disposable Vaginal Speculum
Indications for Use: .
The disposable vaginal speculum is a non-sterile product and is intended to be used by a medical professional to visualize the interior of the vagina and cervix during obstetrical and gynecological examination.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Súbpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Heidi D. Seum
Page Page of
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number