The VacuLink is intended for obstetric use in the measurement and recording of data related to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.

Device Description

The VacuLink is a small, battery powered single-use vacuum measuring device. It is connected in parallel to the vacuum chamber of commercial handheld vacuum assisted delivery systems (i.e. Mityvac & Kiwi PalmPump). As a redundant gauge to the vacuum gauges on those devices, it electronically measures the vacuum applied to the fetal head during a vacuum assisted delivery. It connects to the vacuum port of the maternal/fetal monitor (i.e. HP, Corometrics and Spacelabs) via electrical cable. The vacuum value is numerically displayed in centimeters of mercury (cm Hg). The vacuum value is also recorded from the uterine activity channel of the maternal/fetal monitor and it is permanently stored in the hospital database. The information may also be displayed on a video monitor as well.

The VacuLink incorporates a light sequence of red, yellow, and green. When the VacuLink is first connected to the maternal/fetal monitor, all three lights will flash in sequence as a quick test of the internal components. At the successful completion of the test, the green LED illuminates until the VacuLink is disconnected from the maternal/fetal monitor. A flashing yellow LED illuminates when the battery voltage is low and the VacuLink should be replaced. If a VacuLink that has been used previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational.

AI/ML Overview

Here's an analysis of the provided text regarding the VacuLink device, focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Value	Reported Device Performance
Claimed accuracy/tolerance	At 70 cm Hg = 3.26% on the VacuLink (inherent)	At 70 cm Hg = 3.26% (matches claim)
Comparative Accuracy	At least as accurate as comparable vacuum gauges	"More accurate by a factor of 10" than comparable gauges in clinical use.
Electrical Safety & EMC Conformance	Conformance to applicable standards	"Electrical safety and EMC testing was also performed to demonstrate conformance to applicable standards."
Software Validation	Validated	"Software validation...have also been provided."
Sterilization Process Information	Provided and validated (implied for a single-use device)	"Sterilization process information have also been provided."

Note: The document primarily focuses on the device's accuracy and comparison to predicate devices, rather than explicitly listing "acceptance criteria" as pass/fail thresholds for a primary clinical endpoint. The "Claimed accuracy/tolerance" is presented as a characteristic of the device itself, which then needs to be demonstrated. The comparative accuracy against existing devices could be considered an acceptance criterion for market clearance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Clinical Phase): Not explicitly stated. The document mentions an "Initial clinical phase (feasibility study)" but does not provide details on the number of subjects or cases included in this study.
Data Provenance: Not explicitly stated. Given that the device is manufactured by Medevco, Inc. in Dallas, TX, and the submission is to the FDA, it's likely the clinical feasibility study (if conducted with patients) was in the US. The nature of "Initial bench testing" and "Secondary bench testing" implies laboratory or engineering environments. It's a prospective study as implies "Initial clinical phase (feasibility study)" to study a new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not explicitly stated. The document does not provide details on who established the "ground truth" for the clinical feasibility study, or if "ground truth" for vacuum measurements was established by a separate, highly accurate reference device independent of human interpretation.

4. Adjudication Method for the Test Set

Not explicitly stated. The document does not describe any expert adjudication process for the clinical feasibility study. For the bench testing, the "ground truth" would likely be established by a highly accurate, calibrated reference instrument, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The VacuLink is a vacuum measuring device, not an imaging or diagnostic device that typically involves human interpretation of results in an MRMC study. Its function is to provide an objective measurement (vacuum pressure) and record data. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant to this device.

6. Standalone Performance Study

Yes, a standalone performance study was done implicitly through the "Performance Data & Conclusions" section.

The initial and secondary bench testing phases directly assess the standalone performance of the VacuLink device against certified reference instruments. The statement "Performance testing of VacuLink... reveals that the VacuLink is as accurate as the claimed accuracy" and "VacuLink was more accurate by a factor of 10" (in clinical use, compared to uncalibrated existing gauges) directly addresses its standalone measurement capability.
The "Initial clinical phase (feasibility study)" would also have assessed its standalone functionality in a real-world setting, though specific data from this phase is not provided in detail.

7. Type of Ground Truth Used

Bench Testing: Certified reference instruments (for vacuum measurement).
Clinical Feasibility Study: Implicitly, the actual vacuum applied during an assisted delivery, as measured by the VacuLink and potentially compared to existing devices. The document highlights the "lack of calibration of the comparable vacuum gauges" in clinical use, suggesting the VacuLink aimed to provide a more reliable ground truth in that setting.

8. Sample Size for the Training Set

Not applicable. The VacuLink is a hardware device for measuring vacuum pressure and recording data. It is not an AI/ML-based device that requires a "training set" in the conventional sense. The "training" for such a device involves engineering design, component selection, and calibration, not machine learning model training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" in the context of AI/ML for this device. The accuracy of the device itself would be established through a rigorous calibration process using highly stable and accurate reference pressure gauges.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for MEDEVCO, which is a medical device company. The logo features a stylized "m" followed by the company name in block letters. Above the company name, the date "APR 1 4 2005" is printed.

Appendix C Page 1 of 3

510(k) Summary

Submitter Information:

Medevco, Inc. 12201 Merit Drive, Suite 330 Dallas, TX 75251

Contact:

Ginger Bowman, Director of Marketing Phone: 972.788.4372 Fax: 972.851.0077

Date Prepared:

March 10, 2005

Product Name:

This is an accessory to a fetal vacuum extractor, which is a Class II device per 884.4340. Panel: Obstetrics/Gynecology Product Code: HDB

Predicate Device:

This device is substantially equivalent to the vacuum indicator features of Kiwi brand fetal vacuum extractor systems marketed by Clinical Innovations, Inc., under 1981260, and Mityvac brand vacuum extractor systems marketed by Prism Enterprises (now CooperSurgical) under K011532.

Description:

The VacuLink is a small, battery powered single-use vacuum measuring device. It is The VacuLink is a chianing to the vacuum chamber of commercial handheld vacuum connected in praste tasmig on Mityvac & Kiwi PalmPump). As a redundant gauge to assisted delivery bytters gauges on those devices, it electronically measures the the Dourlow applied to the fetal head during a vacuum assisted delivery. It connects to the vacuunt uppired to the ci.e. HP, Corometrics and Spacelabs) via electrical cable. The maternal is numerically displayed in centimeters of mercury (cm Hg). The vacuum vatually is nambroum the uterine activity channel of the maternal/fetal monitor and it

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is permanently stored in the hospital database. The information may also be displayed on a video monitor as well.

The VacuLink incorporates a light sequence of red, yellow, and green. When the I he VacuLink incorporates a ingav three lights will flash in sequence as a quick test vacurant is internal components. At the successful completion of the test, the green LED of the meethal components: - is disconnected from the maternal/fetal monitor. A munimates until the Vaculine is assets voltage is low and the VacuLink should be nashing you've LED mithoutes are oused previously and is reconnected, the red LED illuminates indicating the VacuLink is no longer operational.

Intended Use:

The VacuLink is intended for obstetric use in the measurement and recording of data The Vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.

SUBSTANTIAL EQUIVALENCE COMPARISON
	VacuLink	Kiwi	Mityvac
Digital display	YES	NO	NO
Permanent record	YES	NO	NO
Disposable	YES	YES	NO
Gauge visible to physician	YES	YES	NO
Ability to display maximum vacuum	YES	YES	YES
Units of vacuum measurement	cm Hg	cm Hg, mm Hg, kPa, in Hg	cm Hg, in Hg
Claimed accuracy/tolerance	at 70 cm Hg = 3.26%	Not published	at 70 cm Hg = 3.27%
Visible display at variable angles	YES	YES	YES
Calibration required by the hospital	NO	NO	YES
Multi-use gauge	NO	NO	YES

Comparison to Predicate Device:

The VacuLink contains additional features including:

Vacuum data recorded on paper strip chart .
I Visible display on CRT
v isibio display on Orimum vacuum, time at maximum vacuum, total time of ■ vacuum, involuntary releases, reduction of vacuum between contractions, and total number of pulls
Light sequencing system to confirm functionality of VacuLink l

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Appendix C Page 3 of 3 K043614

Performance Data & Conclusions:

Performance testing of VacuLink has been conducted in three main phases:

1. Initial bench testing to compare VacuLink technology to certified reference Intial belien testing to comparate in use at community hospitals.
1. Initial clinical phase (feasibility study)
1. Intrail Chinedi phase (reastonity could))

Secondary bench testing on the current configuration of the VacuLink device

Performance testing of VacuLink as well as the reusable handheld vacuum devices Ferrormance testing of VacuLink as accurate as the claimed accuracy of the comparable reveals that the Vacurimis is as accurate as the lack of calibration of the comparable vacuum gauges. In actual cinnical VacuLink was more accurate by a factor of 10.

Electrical safety and EMC testing was also performed to demonstrate conformance Diectived salery and ENTO testing was aftware validation and sterilization process information have also been provided.

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Image /page/3/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle, with its wings spread and its head facing to the left. The eagle is composed of three thick, curved lines that suggest the shape of the bird.

APR 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medevco, Inc. % Ms. Krista Oakes Principal Amica Solutions 2300 McDermott Rd., #200-207 PLANO TX 75025

Re: K043614

Trade/Device Name: Vaculink Regulation Number: 21 CFR 884.4340 Regulation Name: Fetal vacuum extractor Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HDB and HGM Dated: March 10, 2005 Received: March 11, 2005

Dear Ms. Oakes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave icvicwed your becared by equivalent (for the indications for use stated in above and nave determined the devices marketed in interstate commerce prior to the enclosure) to regally mankeled productions of to device Amendments, or to devices that have been lvay 26, 1970, the clacultions and of the Federal Food, Drug, and Cosmetic Act (Act) that Iteliassified in accordanted with the proval application (PMA). You may, therefore, market the do not require approval of a premainer approvins of the Act. The general controls provisions of the Act device, subject to the general conacis prove, listing of devices, 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 (Premarket II your device is classified (see above) into caller than existing major regulations affecting your Approval), It may be subject to such ademons. Title 21, Parts 800 to 898. In addition, FDA device can be nound in the Gour of concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Flease be advised mar 1 27 's 158anies of aevice complies with other requirements of the Act or any FDA hade a decemination administered by other Federal agencies. You must comply with all the Federal statues and regulations administration and listing (21 CFR Part 807); labeling Act S requirements, moduling, but not mixed in the requirements as set forth in the quality systems (QS) (21 CFR Part 801); good namalacting practice the electronic product radiation control provisions (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)
This and the first of the of a line of select of your device to a legall This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA iniding of saostantial of 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), pleased If you desire specific advice for your device on our laboring regarms.
contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to prematet notification" (21 CFR Also, please note the regulation entitled, "visorudion on your responsibilities under the Act from the 807.97). You may obtain other gelleral information on your respections.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address

056-2011 or (3.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hodgdon

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) #: K043614

Device Name: VacuLink

Indications for Use:

The VacuLink is intended for obstetric use in the measurement and recording of data related
of any and the county of any and sumber and duration of pulls and number of The Vacul.ink is intended for obsective use in the measurement.
to vacuum-assisted delivery (such as vacuum, number and duration of pulls and number of pop-offs) on the strip chart.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Ingram

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

Regulation Number and Section

§ 884.4340 Fetal vacuum extractor.

(a)
Identification. A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.(b)
Classification. Class II (performance standards).