(169 days)
Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress.
Standard vacuum extraction
Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions.
Trial of vacuum extraction
Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known.
Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.
The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).
The provided text describes the Kiwi Fetal Vacuum Extractor and its 510(k) submission for market clearance. While it discusses the device's intended use, basic technological characteristics, and comparison to predicate devices, it does not provide detailed acceptance criteria or a specific study that proves the device meets such criteria.
The text generally states:
- "The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing."
- "Biocompatibility testing shows that the materials used in the Kiwi Fetal Vacuum Extractors are safe for this application."
- "Effectiveness is the same as the predicate devices."
- "The laboratory testing verified the performance in terms of vacuum measurement and device integrity."
However, it lacks the specific data points to fill a comprehensive table of acceptance criteria and reported performance, nor does it detail the methodology, sample sizes, ground truth establishment, or expert involvement for the referred "clinical testing" or "laboratory testing."
Therefore, I cannot fulfill all parts of your request based on the provided input.
Here's what can be inferred and what is missing:
Acceptance Criteria and Study Details for Kiwi Fetal Vacuum Extractor
Missing Information: The provided document is a 510(k) summary and FDA clearance letter. It states that "clinical testing" and "laboratory testing" were performed to demonstrate safety and effectiveness similar to predicate devices, and that "laboratory testing verified the performance in terms of vacuum measurement and device integrity." However, it does not provide specific acceptance criteria, detailed results, study designs, sample sizes, or ground truth methodologies for these tests.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Performance/Effectiveness (Inferred/General statements):
| Criterion | Reported Device Performance (General Statement/Inferred) |
|---|---|
| Safety: Biocompatibility | Materials shown to be biocompatible and safe for application. |
| Effectiveness: Equivalence to Predicate | Effectiveness is the same as predicate devices. |
| Performance: Vacuum Measurement | Performance in terms of vacuum measurement verified by laboratory testing. |
| Performance: Device Integrity | Device integrity verified by laboratory testing. |
| Clinical Performance: Successful | Demonstrated in clinical testing (details of success rates, adverse events, etc., are not provided in this summary). |
| Clinical Performance: Similar to Predicate | Safety and effectiveness are similar to existing devices as demonstrated in laboratory and clinical testing. |
Note: Specific quantitative acceptance thresholds (e.g., vacuum pressure range, force limits, successful delivery rates) and actual measured performance values are not provided in this document.
The remaining sections cannot be addressed with specific details from the provided document as the information is not present.
2. Sample size(s) used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature of the clinical/laboratory testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified, as details of clinical or laboratory study design are absent.
4. Adjudication method for the test set
- Not specified.
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/Not specified. This device is a physical medical instrument (fetal vacuum extractor), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical instrument for use by a clinician.
7. The type of ground truth used
- Not explicitly stated for the clinical or laboratory tests. For an interventional device like a vacuum extractor, ground truth would typically relate to successful delivery, Apgar scores, maternal/fetal complications, and physical integrity/functionality of the device.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
{0}------------------------------------------------
SEP 22 1998
K981260
Kiwi Fetal Vacuum Extractor
Clinical Innovations, Inc.
Section 6.0 510(k) Summarv
| Submitter: | Clinical Innovations, Inc. |
|---|---|
| Name: | Wm. Dean Wallace |
| Address: | 6477 So. Cottonwood St., Murray, UT 84107 |
| Telephone: | (801) 268-8200 |
| Fax: | (801) 266-7373 |
| Proprietary Names: | Kiwi Fetal Vacuum Extractors VFE-6000S and VFE-6000M |
|---|---|
| Common/Usual Name: | Fetal Vacuum Extractor |
| Classification Name: | Extractor, Vacuum, Fetal |
The legally marketed devices to which equivalence is claimed are: Mityvac "M" style vacuum extractor (K890307). Mityvac Super "M" Style vacuum extractor (K943928), Mityvac Obstetric Vac Deliv. Kit w/ Univ. VAC REL (K934011), CMI Velvet Touch Vacuum Extractor (K942725). CMI Vacuum Pump #001C (K881967) and Swift Delivery Product #002 (K970170).
Description of the device: The Kiwi Complete Vacuum Delivery Systems are fetal vacuum extractors having a cup to attach to the fetal head, a handle with which to apply withdrawal force, and a vacuum pump built into the handle of the cup/handle combination. This palm pump includes a method for easily generating a vacuum by pumping the handle with the palm. A vacuum indicator and a vacuum relief valve are also integral to the palm pump. Two styles of cups are available; one of soft silicone (VFE-6000S) and the other of the Malmstrom design (VFE-6000M).
Intended use: Use for fetal vacuum delivery assistance in conditions of: 1) dystocia, 2) uterine inertia, 3) maternal exhaustion (ineffective voluntary effort), or 4) maternal or fetal distress.
The Kiwi Fetal Vacuum Extractors are substantially equivalent to the predicate devices because: they have the same intended uses, namely, use for fetal vacuum delivery assistance, and they have the same basic technological characteristics as predicate devices, namely, a hand pump generating a vacuum that attaches a cup to the fetal head and which has a handle for applying force to assist in the delivery of the fetus. They use the same or similar materials, all of which have been shown to be biocompatible and to function well in the intended application.
The safety and effectiveness are similar to existing devices as demonstrated in the laboratory and in clinical testing. Biocompatibility testing shows that the materials used in the Kiwi Fetal Vacuum Extractors are safe for this application. Effectiveness is the same as the predicate devices. The laboratory testing verified the performance in terms of vacuum measurement and device integrity.
Was. Dan Wallace
W. D. Wallace, M.D., Ph.D.
Wm. Dean Wallace, M.D., Ph.D.
4-2-98
Date
Page 8
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus symbol. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1998
Wm. Dean Wallace, M.D., Ph.D. President CLINICAL INNOVATIONS 6477 S. Cottonwood Street Murray, UT 84107
Re: K981260
Kiwi Soft Cup with Palm Pump, Model Nos. VFE-6000M and VFE-6000S (Fetal Vacuum Extractors) Dated: July 8, 1998 Received: July 10, 1998 Regulatory Class: II 21 CFR 884.4340/Procode: 85 HDB
Dear Dr. Wallace:
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.
If your device is classified (see above) into either 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 (OS) 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 531 through 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. Additionaliy, 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/cdrh/dsmaldsmamain.html".
Sincerely vours
Lillian Yin, Ph.D.
Director, Division of Repro Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
09/17/98
Kiwi Fetal Vacuum Extractor Clinical Innovations, Inc.
11.0 Indications For Use
Device Name: Kiwi Fetal Vacuum Extractor
K981260 510(k) Number:
Indications for use:
Standard vacuum extraction
Use for fetal vacuum extraction in conditions of 1) prolonged second stage of labor (arrest of descent) where fetopelvic relationships are adequate, 2) presumed fetal jeopardy which is not considered to be severe, or 3) elective shortening of the second stage for selected maternal or fetal conditions.
Trial of vacuum extraction
Vacuum delivery should be regarded as a "trial" 1) if there is arrest of descent in the second stage and fetopelvic relationships are considered to be boderline, or 2) in a mid-pelvic extraction when position and station are known.
Vacuum extraction should be abandoned and birth completed by cesarean section 1) if no descent (progress) of the head occurs after 2 tractions. 2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.
(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109) /
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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).