(77 days)
The Indications For Use for this vacuum device in childbirth are the following:
Uterine inertia
Maternal Exhaustion - ineffective voluntary effort
Vertex Presentation
Engagement of the Head
Optional:
A. Maternal distress
B. Fetal distress
The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.
The provided text describes a 510(k) premarket notification for a medical device, the "Swift Delivery Product #003 - Vacuum Extractor Cup." This submission is focused on demonstrating substantial equivalence to a predicate device (K970170). Therefore, the information provided primarily concerns the modifications made to the device and the rationale for their safety and effectiveness, rather than a rigorous study with formal acceptance criteria and statistical performance measures typically associated with new technology.
Based on the provided text, a formal study with defined acceptance criteria and performance metrics, as one would find for a novel AI or diagnostic device, was NOT conducted. The submission relies on a comparison to a predicate device and a survey of physicians to justify the improvements.
Here's a breakdown based on your requested information, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense of a new device performance study. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate device K970170.
| Acceptance Criteria (Implicit - based on predicate equivalence) | Reported Device Performance (as claimed by submitter) |
|---|---|
| Functional Equivalence: Cup and stem are substantially equivalent to predicate. | Cup and stem on both products are substantially equivalent. |
| Tubing Attachment/Release Valve: Located and function the same as predicate. | Tubing attachment locations and vacuum release valves are the same. |
| Improved Features: Addition of longer tubing and electric pump adaptor. | New #003 product has 6 feet of tubing (instead of 4 feet) and an adaptor to connect to electric pumps. |
| Safety and Effectiveness (as perceived by physicians): Enhanced safety, reduced delivery time, improved cup, hospital utility. | "The new 003 product WILL INCREASE the SAFETY of delivery for the baby, REDUCE the AMOUNT OF TIME of delivery for the mom, provide an IMPROVED CUP for the physician and be allow the hospital to use existing approved electric vacuum pumps." |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated as a formal "test set" for performance evaluation.
- A "survey was distributed to a select group of physicians in nine states." The exact number of physicians who responded or were part of this "select group" is not provided.
- Data Provenance: Retrospective (based on physician opinions about potential improvements to existing products). Country of origin is the United States (nine states mentioned).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There was no "ground truth" to establish in the context of a performance study for this type of device submission. The "experts" were the "select group of physicians" surveyed, and their qualifications are generally described as "physicians," implying medical doctors who use vacuum extractors in practice. No specific years of experience or sub-specialty (e.g., OB/GYN) are detailed.
4. Adjudication Method for the Test Set
Not applicable. No formal test set or adjudication method was used. The "conclusions" were drawn from the collective opinions gathered in the survey.
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. This is not an AI/software device. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a formal performance study. The "ground truth" for the claims made (e.g., increased safety, reduced delivery time, improved cup) is based on the subjective opinions and perceived needs of the surveyed physicians. There is no objective, independently verified ground truth such as pathology, clinical outcomes, or expert consensus on specific cases.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" for this device. It is a modification of an existing physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for it.
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Swift Delivery Products Submitters Name: 6824 Elk Canyon Road, Okla. City, Okla. 73162 Address: 405-721-8227 Phone : 405-721-8781 Fax : Richard G. Lindsay (Ric Lindsay) Contact Person: This summary was prepared 9-21-97 Date: Swift Delivery Product #003 Name of Device: Common Name: Vacuum Extractor Cup OB/GYN Classification Panel: Product Code: 85HDB (884.4340) C.F.R. Section: CFR - 21 -Device Class: Class Il Indication Use: Vacuum Extractor Cup used in child birth Equivalence to: K970170 Swift Vacuum Extractor with release valve
Description of the Device: The new product is an improved vacuum extractor cup. The improvement is found in the location of the vacuum tubing attachment point, vacuum release valve and an adaptor for electric vacuum pumps.
Description of use: This vacuum device is used in child birth to allow a physician to assist the mother in a safe vaginal delivery.
sarison of our 002 Cup and our new 003 Cup: The cup and stem on both ,ducts are substantial equivalent. The tubing attachment locations and vacuum release valves are the same. The new #003 product has 6 feet of tubing (instead of 4 feet) and an adaptor to connect to electric pumps.
Non-Clinical Performance Data: A survey was distributed to a select group of physicians in nine states. They indicated this improvement (an adaptor and 2 extra feet of tubing) was needed in our vacuum delivery product.
Conclusions drawn from non-clinical data: The vacuum delivery products now in use can be improved. The new 003 product WILL INCREASE the SAFETY of delivery for the baby, REDUCE the AMOUNT OF TIME of delivery for the mom, provide an IMPROVED CUP for the physician and be allow the hospital to use existing approved electric vacuum pumps.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 2 1997
Mr. Richard Lindsay President Swift Delivery Products, Inc. 6824 Elk Canyon Road Oklahoma City, Oklahoma 73162 Re: K973942
Swift Delivery Tulip Vacuum Cup (Product #003) Dated: September 21, 1997 Received: September 26, 1997 Regulatory class: II 21 CFR §884.4340/Product code: 85 HDB
Dear Mr. Lindsay:
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 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 vour 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 requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. FDA may publish further announcements conceming 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 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. Additionally, 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/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K973942
(vice Name: Swift Delivery Product #003 - Vacuum Extractor Cup with Vacuum Release Valve
Indications For Use: 6 feet of tubing and an Adaptor for electric
vacuum pumps.
The Indications For Use for this vacuum device in childbirth are the following:
Uterine inertia
Maternal Exhaustion - ineffective voluntary effort
Vertex Presentation
Engagement of the Head
Optional:
A. Maternal distress
B. Fetal distress
(PLEASE DO 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 Devices
510(k) Number K97.3942
| Labels | Values |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | X |
| 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).