(59 days)
No
The description focuses on a physical measuring device and its equivalence to existing manual uterine sounds, with no mention of AI/ML terms or functionalities.
No
The device is used for measuring purposes only and does not provide any treatment or therapy.
No
The device is described as a measuring sound used to determine the depth and/or length of anatomical structures. It is not described as identifying, evaluating, or predicting a medical condition or disease, which are characteristics of a diagnostic device.
No
The device description explicitly states it is a "single use, disposable device" fabricated from "medical grade plastics," indicating it is a physical hardware device, not software.
Based on the provided information, the Cervilenz Measuring Sound is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Cervilenz Function: The Cervilenz Measuring Sound is a physical device used for measuring the depth and/or length of the uterus, cervix, and vagina. It is inserted into the body to obtain a physical measurement.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a direct measurement tool.
Therefore, the Cervilenz Measuring Sound falls under the category of a medical device used for physical measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
Product codes
85 HHM
Device Description
The Cervilenz Measuring Sound is a single use, disposable device used for measuring the depth and/or length of the uterus, cervix and vagina. The operating principle of the Cervilenz Measuring Sound is the same as that of cleared, commercially-available uterine sounds, and is based on insertion of the device into the cervical canal in order to obtain measurements. The Cervilenz Measuring Sound is fabricated from medical grade plastics of known biocompatibility and with a history of human use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus, cervix, vagina
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)
The Cervilenz Measuring Sound was found to perform equivalently to commercially-available uterine sounds when evaluated for accuracy and reproducibility of measurements. Thus, the technological changes in the Cervilenz Uterine Sound do not raise any new issues of safety, effectiveness or performance of the product.
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
AUG 1 0 2001
Confidential Premarket Notification
K011 840
Page 1 of 2
SECTION 11
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in Fills STO(t) buth the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's name, address, telephone number, contact person, and date 1. summary prepared;
- Cervilenz, Inc. Applicant a. 17752 Sky Park Circle, Suite 285 Irvine, CA 92614 (949) 975-1515
- Judy F. Gordon, D.V.M. b. Contact Person: ClinReg Consulting Services, Inc. (949) 854-6314
- June 7, 2001 Date Summary Prepared: c.
Name of device, including trade name and classification name: 2.
| a. | Trade/Proprietary Name: | Measuring Sound |
|---|---|---|
| b. | Classification Name: | Uterine Sound |
Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:
| Company: | Cook OB/GYN |
|---|---|
| Device: | Teflon Uterine Sound |
| 510(k) : | K870550 |
| Date Cleared: | 1987 |
| Company: | Searle Laboratories |
| Device: | Mark-7 Disposable Uterine Sound |
| 510(k) : | K760170 |
| Date Cleared: | 1976 |
1
K011840
Page 2 of 2
A description of the device that is the subject of the 510(k), including 4. explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The Cervilenz Measuring Sound is a single use, disposable device used for measuring the depth and/or length of the uterus, cervix and vagina. The operating principle of the Cervilenz Measuring Sound is the same as that of cleared, commercially-available uterine sounds, and is based on insertion of the device into the cervical canal in order to obtain measurements. The Cervilenz Measuring Sound is fabricated from medical grade plastics of known biocompatibility and with a history of human use.
ડ. Statement of intended use:
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
Statement of how the technological characteristics of the device compare to 6. those of the predicate or legally marketed device.
The technological characteristics of the Cervilenz Measuring Sound are comparable to those of the predicate and legally marketed uterine sounds, with regard to dimensions, materials of fabrication, and operating principle.
7. Brief summary of nonclinical tests and results:
The Cervilenz Measuring Sound was found to perform equivalently to commerciallyavailable uterine sounds when evaluated for accuracy and reproducibility of measurements. Thus, the technological changes in the Cervilenz Uterine Sound do not raise any new issues of safety, effectiveness or performance of the product.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2001
Cervilenz, Inc. c/o Judy F. Gordon, D.V.M. Regulatory Consultant ClinReg Consulting Services, Inc. 18732 Saginaw IRVINE CA 92612
Re: K011840 Cervilenz™ Measuring Sound Dated: June 11, 2001 Received: June 12, 2001 Regulatory Class: I 21 CFR§884.4530/Procode: 85 HHM
Dear Dr. Gordon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have and associetes we have reviewed your Scholl 310x) nombations of muse stated in the enclosure) to legally marketed predicate devices device is stossimally equivalent (tot the materient and the Medical Device Amendments, or to devices of to devices of to devices of to devices of to devices of to devices of marketed in mierslate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been recalasmed in accordance will als provisions of the Act. The general controls provisions of the Act therefore, market the device, subject of the Editoris pro nectice, labeling practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premater Approval), it may be subject of Enders Results of President President President President If your device is classined (Secadore) into clubs it (Openal Ocentrely or the form in the Code of Feceral Regulations, to such additional controls. Existilly equivalent detecting yourses compliance with the Current Good Manufacturing (11 (CE) Pre 11th 21, Parts 800 0 693. A substantialion (QS) for Medical Devices: Cencral regulation (21 CFR Partice requirements, Foiling Practice requirencens, as set than in the Quality Dyson regulation (FDA) will verify such assumptions. Failure 620) and may with the GMP regulations, the regulatory action. In addition, FDA may publish further announcements to comply will the GMP Tegulation nay result in regulation on this response to your premarket notification submission the dust concerning your device in the Four Regiser. Trease nown responses under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding I fills letter will allow you to obgally 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 and additionally 809.10 for in vitro If you desire specific dovice tor your device of Compliance at (301) 594-4639. Additionally, for questions on the promision ulaghosite 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 807.97). Other general information on your entined, "Misolanding of Petericanoli" (area in " (ar of Sreal) Manufacturers Assistance at its toll-free number (800) 138-2011 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
3
Page 1 of 1
510(k) Number (if known): KO II840
Device Name: Cerileuz Measuring Sound
Indications for Use:
The Cervilenz Measuring Sound is used for measuring the depth and/or length of the uterus, cervix and vagina.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use
OR
Nancy C. Bergdon
(Division Sign-Off)
Over-The-Counter Use (Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K011840