This document is a 510(k) summary for the "Joey Clamp Opening Tool". It states that the device is "substantially equivalent" to an existing legally marketed device, the "Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263]". This type of submission (510(k)) does not typically require extensive clinical studies with detailed acceptance criteria and performance data as would be found in a Premarket Approval (PMA) application. For 510(k) devices, the primary demonstration is substantial equivalence to a predicate device.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.), and expert qualifications is not explicitly provided in this 510(k) summary because it is generally not a requirement for this type of regulatory submission. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

However, I can extract and infer some high-level information based on the document:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission, there isn't a table of quantitative acceptance criteria and reported device performance in the same way a clinical trial would present it. The acceptance is based on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

Acceptance Criteria for 510(k): The device is substantially equivalent to the predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or it has the same intended use and different technological characteristics but the new device does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
Reported Device Performance: "The Joey Clamp Opening Tool is substantially equivalent to the Secureline® Umbilical Cord Clamp Clipper [510 (k) No. K994263] that is legally marketed in the U.S." The stated intended use is "to open the Joey Clamp umbilical cord clamp." The performance required is simply the ability to open the specified clamp in a safe and effective manner, comparable to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable for this 510(k) summary. No specific clinical test set details are provided.

3. 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 applicable for this 510(k) summary. No ground truth establishment by experts for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable for this 510(k) summary. No adjudication method for a test set is described.

5. 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 for this device. This is a manual tool, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable for this device. This is a manual tool, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable for this 510(k) summary. The "ground truth" for a 510(k) generally refers to the safety and effectiveness profile of the predicate device, which is already legally marketed.

8. The sample size for the training set:

Not applicable for this device. No training set is involved as it is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable for this device. No training set ground truth establishment is described.

Summary

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41332

JUN 2 5 2004

510(K) Summary

Substantial Equivalence & Safety & Effectiveness Information

[September 3, 2003]

I. Proprietary Name:	Joey Clamp Opening Tool
II. Common Name:	Umbilical Cord Clamp Opening Tool
III. Classification Name:	Umbilical Clamp (HFW)
IV. Substantial Equivalence	The Joey Clamp Opening Tool is substantiallyequivalent to the Secureline® Umbilical CordClamp Clipper [510 (k) No. K994263] that islegally marketed in the U.S.
V. Statement of Intended Use:	The indications for use of the Joey Clamp OpeningTool is to open the Joey Clamp umbilical cordclamp.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2004

Mr. Ronald B. Hicks Vice President and COO Maternus, Inc. 15303 Huebner Road, Building 10 SAN ANTONIO TX 78248

Re: K041332

Trade/Device Name: Joey Clamp Opening Tool Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecology specialized manual instrument Regulatory Class: II Product Code: 85 HFW Dated: May 10, 2004 Received: May 19, 2004

Dear Mr. Hicks:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becemined the device is substantially equivalent (for the indications felerenced above and nave o retro legally marketed predicate devices marketed in interstate for use stated in the enolosare) to regary to regard date of the Medical Device Amendments, or to commerce proct to may 20, 2014) 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 Tournal controls provisions of the Act include requirements for annual registration, listing of gences, 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 such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and th may be subject to back as a leader a Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the 0000 cements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I rease oc advised that I Dris issualled on our device complies with other requirements of the Act that FDA has made a determinations administered by other Federal agencies. You must comply or any I cacar statures and regains including, but not limited to: registration and listing (21 CFR Part with an the Ace 3 requirements, merablements of equirements as set forth in the 807); laboring (21 CFR Part 820); and if applicable, the electronic product quality Systems (QB) issgms (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
Children and consisted and consisted as a least of your device to a legal This letter will allow you to begin harkcang your aving equivalence of your device to a legaliy
premarket notification. The FDA finding of substantial equivalence ond thus, premarket notification. The PDA Inding of substantial equivals 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
r the regulation If you desire specific advice for your device on our laboling numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotion and and the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Also, please note the regulation of the re Office of Compliance at (301) 374-4037. Thise, preasons of the Pinise of Space by reference to premarket notification (21 OF Act are and the firm the Division of Small information on your responsionities uncer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of the Indensements html Mandiacturers, International and Colleamer Posterial Provedrh/dsma/dsmamain.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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

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Indications for Use

510(k) Number (if known): K041332

Device Name:	Joey Clamp Opening Tool
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The indications for use of the Joey Clamp Opening Tool is to Indications For Use: open the Joey Clamp® umbilical cord clamp.
V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel h. Lyman
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

Page 1 of __1

Regulation Number and Section

§ 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.