(77 days)
The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord.
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This is a medical device 510(k) premarket notification for the Koala Clamp & Cutter, an umbilical cord clamp and cutter device. The submission aims to demonstrate substantial equivalence to a predicate device, the ClampCut by PriceInvena APS (510(k) No. 982464).
Given the nature of this submission, which is for a physical medical device (an umbilical cord clamp and cutter) and not an AI/ML-driven diagnostic or prognostic device, the concepts of "acceptance criteria," "device performance" in the context of AI metrics (like sensitivity, specificity), "sample size for test/training sets," "ground truth establishment by experts/pathology," "MRMC studies," or "standalone algorithm performance" are not applicable.
The document focuses on comparing the physical characteristics, materials, intended use, and general performance attributes (like sterility) of the Koala Clamp & Cutter to its predicate device. This is a common approach for 510(k) submissions for non-software/AI devices, where substantial equivalence is demonstrated through engineering and material comparisons, and potentially performance testing related to its mechanical function.
Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device evaluation. The document does not contain data or studies related to AI/ML performance.
However, I can extract the comparison chart provided, which highlights the device's technical specifications:
1. Table of Acceptance Criteria and Reported Device Performance
(Note: "Acceptance Criteria" here refers to the comparison points for substantial equivalence, not AI performance metrics. "Device Performance" refers to the characteristics of the Koala Clamp.)
| Comparison Characteristic | Koala Clamp | Predicate Device (ClampCut SCC-23) |
|---|---|---|
| Indications for Use | Simultaneously clamp and cut the umbilical cord. | Simultaneously clamp and cut the umbilical cord. Reduces risk to healthcare practitioners of unnecessary exposure to infection by bloodborne diseases. |
| Target Population | All births | All births |
| Materials: Plastic | Lexan 144R (alternate: Lexan 124R) | Polyamid 6.6. |
| Biocompatible | Yes | Yes |
| Materials: Blade | Stainless Steel Surgical Blade | Stainless Steel Knife |
| Shield (for Blade) | Yes | No |
| Dimensions: Open Unit | 74mm x 50.6mm x 32.9mm | 120mm x 70mm x 20mm |
| Dimensions: Closed Unit | 46.8mm x 50.6mm x 32.9mm | 85mm x 60mm x 20mm |
| Dimensions: Infant Clamp | 43.5mm x 23.9mm x 6.5mm | 50mm x 9mm x 7mm |
| Weight of Total Unit | 1.316 oz | 0.811 oz (23 grammes) |
| Weight of Cutter Unit alone | 0.53 oz | 0.713 oz (20.2 grammes) |
| Weight of Infant Clamp alone | 0.086 oz | 0.099 oz (2.8 grammes) |
| Sterility | Gamma-Sterilized (alternate: Ethylene Oxide Gas) | Ethylene Oxide Gas |
| Anatomical Sites | Umbilical Cord | Umbilical Cord |
The remaining requested information (2-9) is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML-driven diagnostic/prognostic tool. There are no AI algorithms, test sets, training sets, ground truth derived from expert consensus, or MRMC studies described in this document. The "study" proving the device meets criteria is implicitly the declaration of substantial equivalence based on the comparison of physical and performance characteristics to a legally marketed predicate device.
§ 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.