(27 days)
The SCC-23 Safety Clamp and Cutter is intended to simultaneously cut and clamp the umbilical cord following birth. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases.
The SCC-23 Safety Clamp and Cutter is a pre-sterilized, ready-to-use, disposable obstetric instrument comprising a piston housing and two clamps manufactured of Polyamid 6.6 (nylon) which, upon incineration, converts to water vapor. The product also incorporates a stainless steel blade protectively sealed within the piston. The entire device weighs approximately 0.8 ounces or 23 grams. The clamp weighs approximately 0.1 ounces or 2.8 grams.
The provided document is a 510(k) summary for the SCC-23 Safety Clamp and Cutter, which is a medical device intended to simultaneously cut and clamp the umbilical cord. This submission is for substantial equivalence to a predicate device, not for a de novo marketing authorization that would typically require extensive clinical studies to establish acceptance criteria and device performance. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth establishment.
Here's an explanation based on the available information:
- A table of acceptance criteria and the reported device performance: Not available. This document is a 510(k) summary focusing on substantial equivalence, not a clinical trial report with performance metrics and acceptance criteria.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available. No clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not available. No study requiring expert ground truth is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available. No study requiring adjudication is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a manual obstetric instrument, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a manual obstetric instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available. No study requiring ground truth is described.
- The sample size for the training set: Not applicable. This device is a manual obstetric instrument, not a learned algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided document:
The 510(k) submission for the SCC-23 Safety Clamp and Cutter focuses on its substantial equivalence to a predicate device, Veridien Corporation's umbilical clamping shear (K963428).
- Intended Use: "The SCC-23 Safety Clamp and Cutter is intended to simultaneously cut and clamp the umbilical cord following birth. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases."
- Comparison: Both devices "comprise two clamps and a cutter designed to simultaneously clamp and cut the umbilical cord."
- Conclusion: The FDA determined the device to be "substantially equivalent" to the predicate, allowing it to be marketed. This determination is based on the comparison of technological characteristics and intended use, rather than extensive clinical performance studies that would establish specific acceptance criteria and provide detailed study results as requested in your prompt.
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AUG 1 1 1998
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510(k) SUMMARY
Page 1 of 2
982464
SUBMITTER'S NAME:
ADDRESS:
TELEPHONE:
FAX:
CONTACT PERSON:
DATE PREPARED:
NAME OF DEVICE:
PRODUCT CODE:
CLASS:
Proprietary Name:
Common/Usual Name:
Classification Name:
CLASSIFICATION REGULATIONS:
12220 El Camino Real, Suite 400
Women First HealthCare, Inc.
San Diego, California 92130
(619) 509-1171
(619) 509-1353
Jeanne-Marie Varga Vice President Regulatory Affairs and Quality Systems
July 13, 1998
SCC-23 Safety Clamp and Cutter
Umbilical clamp and cutter
Umbilical Clamp Umbilical Scissors Ob/Gyn Specialized Manual Instruments
85 HFW, HDJ, & KNA
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21 CFR 884.4530
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K982464
1292
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Page 2 of 2 510(k) SUMMARY (Cont.)
PREDICATE DEVICE: Veridien Corporation's umbilical clamping shear, K963428
DESCRIPTION OF DEVICE: The SCC-23 Safety Clamp and Cutter is a pre-sterilized, ready-to-use, disposable obstetric instrument comprising a piston housing and two clamps manufactured of Polyamid 6.6 (nylon) which, upon incineration, converts to water vapor. The product also incorporates a stainless steel blade protectively sealed within the piston. The entire device weighs approximately 0.8 ounces or 23 grams. The clamp weighs approximately 0.1 ounces or 2.8 grams.
INTENDED USE: The SCC-23 Safety Clamp and Cutter is intended to simultaneously cut and clamp the umbilical cord following birth. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: Both the SCC-23 Safety Clamp and Cutter and the Veridien Corporation umbilical clamping shear comprise two clamps and a cutter designed to simultaneously clamp and cut the umbilical cord.
SUBSTANTIAL EQUIVALENCE: The SCC-23 Safety Clamp and Cutter is substantially equivalent to the umbilical clamping shear from Veridien Corporation, St. Petersburg, Florida, K963428.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG / 1 1998
Ms. Jeanne-Marie Varga Vice.President Regulatory Affairs and Quality Systems WOMEN FIRST Health Care 12220 El Camino Real Suite 400 San Diego, CA 92130
Dear Ms. Varga:
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.
Re: K982464
SCC-23 Safety Clamp and Cutter
21 CFR 884.4530/Procode: 85 KNA
Dated: July 13, 1998
Regulatory Class: II
Received: July 15, 1998
If your device is classified (see above) into either class II (Special Controls) or class III (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 equivalent determination assumes compliance 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 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 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 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/odrh/dsmadsmam.html".
Sincerely vours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
K'98 24 64
Device Name: SCC-23 Safety Clamp and Cutter
Indications for Use:
The indications for use of the SCC-23 Safety Clamp and Cutter are to simultaneously clamp and cut the umbilical cord. The device reduces the risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Diseases
510(k) Number K982464
Prescription Use X
or
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.