(250 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (circumcision clamp) with no mention of AI/ML, image processing, or performance studies related to algorithmic analysis.
Yes
A circumcision clamp is a surgical instrument used to perform circumcisions, which is a medical procedure. Surgical instruments are considered therapeutic devices as they are used to treat or prevent a medical condition.
No
The device is described as a "Circumcision Clamp," which is a surgical tool used for a procedure, not for diagnosing a condition.
No
The device description explicitly states "Circumcision Clamp," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to testing samples from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as a "Circumcision Clamp." This is a surgical instrument used for a procedure performed directly on the patient, not for testing samples in vitro.
- Lack of IVD-related information: The document lacks any mention of sample types, analytes, testing procedures, or any other information typically associated with IVDs.
Therefore, based on the available details, the device is a surgical instrument and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Common Name: Circumcision Clamp
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Mogan Clamp
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
11
510(k) Summary
The safety and effectiveness information upon which the substantial equivalence determination is based on the Mogan clamp. This clamp is a predicate device that was legally marketed in the United States prior to May 28, 1976.
Submitter's name:
Frederic Steinberg, DO 40 Cooper Run Drive Cherry Hill, NJ 08003 (609) 424-7250
and
Phyllis Adams, RN, NPC, MSN 27 Lady Diana Circle Marlton, NJ 08053 (609) 983-8561
Fax Number:
Contact Person:
(609) 261-4327 Attention: Phyllis Adams
Phyllis Adams 27 Lady Diana Circle Marlton, NJ 08053
Date of Summary:
Name of Device:
Trade Name: EZ-CIRC
November 8, 1995/
January 31, 1997
Common Name: Circumcision Clamp
Classification Name: Obstetrical and Gynecological Devices (884.4520)
Identification of legally marketed device which claiming equivalence: Mogan Clamp
Image /page/0/Picture/17 description: The image shows a handwritten text that appears to be a combination of letters and symbols. The text includes the letters 'O' and 'B' stacked on top of each other, followed by a diagonal line and the letter 'I'. Below these characters, there are some additional markings that are difficult to decipher due to their small size and unclear formation. The overall impression is that of a quick note or label written in a casual manner.