(87 days)
No
The device description and intended use clearly describe a manual surgical kit with no mention of software, algorithms, or any technology that would suggest AI/ML.
Yes.
The device is intended to treat urinary incontinence by placing a suburethral sling, thus directly addressing a medical condition.
No
This device is a surgical kit designed to place a urethral sling for the alleviation of urinary incontinence, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states the kit is comprised of physical components (needles, sheaths, loops) made of surgical stainless steel and polyethylene, indicating it is a hardware medical device.
Based on the provided information, the UroMed Sling Kit 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 UroMed Sling Kit is a surgical kit used during a surgical procedure to implant a sling beneath the urethra. It is a tool used by a surgeon on the patient's body, not for testing samples taken from the body.
The description clearly states its intended use is for a surgical procedure to alleviate urinary incontinence and describes the surgical instruments included in the kit. There is no mention of analyzing biological samples.
N/A
Intended Use / Indications for Use
The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of involuntary leakage of urine due to urinary incontinence in adult women.
The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes
85 KNA
Device Description
The UroMed Sling Kit is a single use, manual surgical kit for use during suburethral sling procedures. The kit will be used to place a sling (autograph, allograph, or synthetic) beneath the urethra in suburethral sling procedures.
The kit is comprised of two needles, two sheaths and two loops.
The kit components are constructed out of the following materials:
Needle: Surgical Stainless Steel, meeting ASTM Specification F899-84, with a handle constructed of Polyethylene Terephthalate (PET-P).
Sheath: Polyethylene
Loop: Surgical Stainless Steel, meeting ASTM Specification F899-84, with Polyethylene shaft
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra
Indicated Patient Age Range
adult women
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K933698, Unknown, K881224 and K926036
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
Plaz
510(k) Summary of Safety and Effectiveness UroMed Sling Kit
Company Name
UroMed Corporation 64 A Street Needham, MA 02194
Official Contact
Nancy C. MacDonald Manager, Clinical and Regulatory Affairs
Device Name
Proprietary Name: Common Name: Classification Name: UroMed Sling Kit Sling Kit 21 CFR § 876.4730 Manual Surgical Instruments
Predicate Devices used for Substantial Equivalence
Device
Cook Loop Retriever Cook Stamey Needle Cook Fascial Dilator Acufex Suture Retriever
Premarket
K933698 Pre-Amendment Unknown K881224 and K926036
Intended Use
The UroMed Sling Kit is intended to be used in a suburethral sling procedure for the alleviation of involuntary leakage of urine due to urinary incontinence in adult women.
Indications for Use
The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.
1
Description
P2092
The UroMed Sling Kit is a single use, manual surgical kit for use during suburethral sling procedures. The kit will be used to place a sling (autograph, allograph, or synthetic) beneath the urethra in suburethral sling procedures.
The kit is comprised of two needles, two sheaths and two loops.
The kit components are constructed out of the following materials:
Needle: Surgical Stainless Steel, meeting ASTM Specification F899-84, with a handle constructed of Polyethylene Terephthalate (PET-P).
Sheath: Polyethylene
Loop: Surgical Stainless Steel, meeting ASTM Specification F899-84, with Polyethylene shaft
Summary of Standards Achieved
ASTM F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments.
ISO 10993-1, "Biological evaluation of medical devices -- Part 1: Gudiance on selection of tests".
Summary
In summary, the UroMed Sling Kit is substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
MAY 22 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Nancy C. MacDonald Manager. Clinical and Regulatory Affairs Uromed Corporation 64 A Street Needham, MA 02194
Re: K980717 Uromed® Sling Kit Dated: February 20, 1998 Received: February 24, 1998 Regulatory class: II 21 CFR §884.4530/Product code: 85 KNA
Dear Ms. MacDonald:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalience with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D
Director, Division of Reproductiv Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Premarket Notification UroMed Sling Kit
510(k) Number (if known): K98 C アイ
Device Name: UroMed Sling Kit
Indication for Use:
The UroMed Sling Kit is indicated for use by the surgeon for placing a urethral sling. The kit provides instruments to help the surgeon place the sling beneath the urethra. The kit will be used in suburethral sling procedures for female urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: را (Per 21 CFR 801.109)
.
UroMed Sling Kit - 510(k) 2/20/98
OR
Over-The-Counter Use
Robert R. Rathbun
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number _
39
. . .