(85 days)
Not Found
The provided text mentions "DND 101™ device" as a Reference Device. However, it does not include any K/DEN numbers for this device. Therefore, I cannot identify the K/DEN number for the Reference Device.
No
The device description details a purely mechanical surgical instrument operated manually by the surgeon, with no mention of computational processing, algorithms, or data analysis that would indicate AI/ML.
Yes
The device is used for surgical treatment of medical conditions like pelvic organ prolapse and urinary incontinence.
No
The device description indicates it is a surgical tool used for treatment (anchoring suture material) and not for identifying or assessing a medical condition. While the "Intended Use / Indications for Use" mentions "manipulative diagnostic and surgical functions" for a group of devices, the specific description of the UroGyn DND 202™ focuses solely on its surgical application.
No
The device description clearly states it is a surgical tool consisting of a plastic thimble connected to an operating box, containing a surgical needle and suture cartridge. This describes physical hardware components, not software.
Based on the provided information, the UroGyn DND 202™ Manual Urological Digital Needle Driver is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The UroGyn DND 202™ is a surgical instrument used during a surgical procedure on the patient's body.
- The intended use and device description clearly state its function is to perform manipulative diagnostic and surgical functions directly on the patient's anatomy. It's used for anchoring suture material to tissue during surgery, not for analyzing biological samples.
- The device description focuses on its mechanical function and how it interacts with tissue and suture material. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the UroGyn DND 202™ is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The general purpose of the device as defined in 21 CRF 884.4530: 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. The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of Pelvic organ prolapse/vaginal prolapse and is equivalent to the currently employed procedure, which is performed with the Deschamps™ device, distributed by BEI Medical Systems Corporation. The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.
Product codes
KNA
Device Description
The UroGyn DND 202™ device is a surgical tool, consisting of a plastic thimble connected to an operating box. The thimble element of the device contains a surgical needle and a cartridge preloaded with suture material. The DND 202™ is mounted on the surgeon's index finger and controlled externally. DND 202™ allows the surgeon to operate guided by palpation only. The device is used to anchor the suture material to dense connective tissue at the hipbone during Bladder Neck Suspension for the treatment of Urinary Incontinence or Pelvic Organ Prolapse. The vaginal mucosa is open through surgical incision and the surgeon's finger, with the thimble of the DND 202 mounted on it, is placed through the incision to palpate the desired anatomical structure. The device is then operated externally by the other hand causing the projection of the surgical needle into the tissue. The needle reaches the opposite side of the device and retrieves the suture material from the cartridge. A reverse motion of the needle with the suture material hooked at the tip of the needle retracts the needle back into its housing. The surgeon remove his hand with the device out of the vagina, release the suture material from the needle and ends up with two ends of the suture material anchored to the target connective tissue and ready for tying.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic organ, vaginal, hipbone, bladder neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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)
Deschamps™ device
Reference Device(s)
DND 101™ device
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
MAR 2 1 2002
Page 1 of 3
Section 20.
510(k) Summary of Safety and Efficacy
Date:
December 31, 2001
Submission by:
UroGyn Ltd. Diamond Tower (26th Floor) 3A Jabotinski Street Ramat Gan 52520 Israel Telephone: 972-3-6122254 Fax: 972-3-6133275
Contact Person:
Erez Adiv Telephone: 972-5-3696076
Name of Device:
DND 202TM Manual Urological Digital Needle Driver
Classification:
21 CRF 884.4530 Obstetric-gynecologic specialized manual instrument.
Regulatory Class:
Class II.
1
Product Code:
KNA – Obstetricgynecological specialized manual instrument.
Intended Use:
The general purpose of the device as defined in 21 CRF 884.4530:
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.
Indication for Use:
The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of Pelvic organ prolapse/vaginal prolapse and is equivalent to the currently employed procedure, which is performed with the Deschamps™ device, distributed by BEI Medical Systems Corporation.
The UroGyn DND 202™ device is a surgical tool, consisting of a plastic thimble connected to an operating box. The thimble element of the device contains a surgical needle and a cartridge preloaded with suture material.
The DND 202™ is mounted on the surgeon's index finger and controlled externally. DND 202™ allows the surgeon to operate guided by palpation only. The device is used to anchor the suture material to dense connective tissue at the hipbone during Bladder Neck Suspension for the treatment of Urinary Incontinence or Pelvic Organ Prolapse. The vaginal mucosa is open through surgical incision and the surgeon's finger, with the thimble of the DND 202 mounted on it, is placed through the incision to palpate the desired anatomical structure. The device is then operated externally by the other hand causing the projection of the surgical needle into the tissue. The needle reaches the opposite side of the device and retrieves the suture material from the cartridge. A reverse motion of the needle with the suture material hooked at the tip of the needle retracts the needle back into its housing. The surgeon remove his hand with the device out of the vagina, release the suture material from the needle and ends up with two ends of the suture material anchored to the target connective tissue and ready for tying.
43
2
Page 3 of 3
Conclusions:
From UroGyn's experience we believe that the UroGyn design offers an equally effective alternative to the DND 101™ device and/or the Deschamps™ device for the treatment of female vaginal prolapse. Furthermore, as a minimally invasive procedure, we also believe that it presents equal safety to the patient and surgeon.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right. The bird is composed of three curved lines that suggest feathers or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2002
Mr. Erez Adiv Consultant UroGyn Ltd. Diamond Tower (26th Floor) 3A Jabotinski Street Ramat Gan 52520 ISRAEL
Re: K014248 Trade/Device Name: Urogyn DND 202™ Manual Urological Digital Needle Driver Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 KNA Dated: December 15, 2001 Received: December 26, 2001
Dear Mr. Adiv:
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.
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.
4
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 19.
Indication For Use Statement
510(k) Number (if known):
Device Name:
DND 2027M Manual Urological Digital Needle Driver
Indication For Use:
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.
The UroGyn DND 202™ Manual Urological Digital Needle Driver is indicated for use during surgical treatment of vaginal prolapse.
(PLEASE DO NOT WRITE BELOW THE LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Jamil G. Ingram
510(k) N
Over-The-Counter Use
(Optional Format 1-2-96)