(311 days)
Not Found
No
The device description and intended use focus on a mechanical vacuum extraction device with no mention of AI or ML capabilities.
Yes
The device is used to facilitate the delivery of the fetus during childbirth, specifically to apply traction to the fetal head. This direct intervention on the body to improve a health condition (delivery) aligns with the definition of a therapeutic device.
No
The device is used to facilitate the delivery of the fetus by applying traction to the fetal head, which is an intervention, not a diagnostic process.
No
The device description clearly states it is a sterile, disposable device made of an elastomer with a handle and suction cup, indicating it is a physical hardware device.
Based on the provided information, the Medela® Single Use Silc Cup is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the Medela® Single Use Silc Cup is to facilitate the delivery of a fetus during childbirth by applying traction to the fetal head. This is a direct intervention on the patient, not an examination of a specimen.
- The device description and intended use clearly describe a physical medical device used for a surgical/obstetric procedure. There is no mention of analyzing blood, tissue, or any other bodily fluid or substance.
Therefore, the Medela® Single Use Silc Cup falls under the category of a medical device used for a clinical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. 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. It is larmedd by an external vacuum source and indicated for using during vaginal or cesarean delivery.
The Indications for use are
- Fetal distress in the second stage
- Maternal delay in the second stage
- Maternal conditions requiring a short second stage
Conditions for use of the Single Use Silc Cup
- Vertex presentation, with the head well-flexed
- Ruptured membranes
- Gestational age > 36 weeks
- Cervix fully dilated
- Head fully engaged abdominally
Product codes
HDB
Device Description
The Medela® Single Use Silc Cup is a sterile, disposable device made of an elastomer and available in one size, 60mm inner diameter. The instrument is elastomer and consists of a handle and a suction cup to be used with an external vacuum pump and tubing.
The cup has a smooth external surface with a small longitudinal ridge, which makes it possible to observe any rotation. The inside of the cup is lined with mance it possible to objections enable the air between the cup and the child's Small projoctions: The projections that the cup sucks firmly against the child's head. The soft suction cup deforms, thereby ensuring optimal adhesion and minimizing trauma to the fetal scalp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fetal head (in the birth canal)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Medela AG, Laettichstrasse 4b, CH-6341 Baar, Switzerland Applicant: Appliaan:
Contact Person: Werner Frei, Te! +41 (41) 769 51 51 ext. 247; Fax +41 (41) 769 51 00 werner.frei@medela.ch
510(k) Submission for Medela® Obsteirical Vacuum Delivery System
APR 2 1 2005
KO41579
Section E - 510(k) Summary
Medela Obstetrical Vacuum Delivery System
Sponsor's Name, Address and Contact Person: 1
Contact Person Sponsor: Werner Frei Medela AG Manager Regulatory Affairs Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 5151 ext. 228 Phone: Fax: +41 41 769 5100
Date Summary Prepared: March 01 2004
Name of Device(s) 2
| Trade Name: | Medela® Single Use Silc Cup |
|---|---|
| Fetal Vacuum Extractor |
| Common Name: | Obstetrical Vacuum Delivery System |
|---|---|
| Classification Name: | Fetal Vacuum Extractor, Obstetrical and Gynecological Surgical |
| (Classified Class II, per 21 CFR Section § 884.4340). |
Product Code 3
HDB
Name of the predicate Device(s) 4
| Medela Inc. | OB Vacuum Extractor
(K841492) |
|----------------|---------------------------------------------------------------|
| Hollister Inc. | Ameda/Egnell Dolphin Dispo-Soft Vacuum Extractor
(K895700) |
1
Description of Device 5
The Medela® Single Use Silc Cup is a sterile, disposable device made of an elastomer and available in one size, 60mm inner diameter. The instrument is elastomer and consists of a handle and a suction cup to be used with an external vacuum pump and tubing.
The cup has a smooth external surface with a small longitudinal ridge, which makes it possible to observe any rotation. The inside of the cup is lined with mance it possible to objections enable the air between the cup and the child's Small projoctions: The projections that the cup sucks firmly against the child's head. The soft suction cup deforms, thereby ensuring optimal adhesion and minimizing trauma to the fetal scalp.
Intended Use of the Device රි
The Medela® Single Use Silc Cup is intended to be used to facilitate the delivery of the fetus during childbirth. 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. It is larmedd by an external vacuum source and indicated for using during vaginal or cesarean delivery.
The Indications for use are
- Fetal distress in the second stage ﻬ
- Maternal delay in the second stage +
- Maternal conditions requiring a short second stage .
Conditions for use of the Single Use Silc Cup
- Vertex presentation, with the head well-flexed �
- Ruptured membranes +
- Gestational age > 36 weeks .
- Cervix fully dilated ↓
- Head fully engaged abdominally +
2
510(k) Submission for Medela® Obstetrical Vacuum Delivery System
Summary of Technological Characteristics 7
The Technology of the Medela® Single Use Silc Cup is identical to the predicate rne Toomology of the no technical differences which would raise new aspects regarding safety and effectiveness.
Based upon the information presented in section I - Biocompatibility, the materi-Dased upon the miomation prose Single Use Silc Cup are considered as appropriate for their intended use.
Conclusion 8
Based upon the information presented above, it is concluded that the proposed Medela® Single Use Silc Cup is safe and effective for the intended use and is substantially equivalent to the predicate devices.
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
Medela AG % Mr. Stefan Preiss Responsible Third Party TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K041579
Trade/Device Name: Medela® Single Use Silc Cup Regulation Number: 21 CFR 884.4340 Regulation Name: Fetal vacuum extractor Regulatory Class: II Product Code: HDB Dated: April 1, 2005 Received: April 6, 2005
Dear Mr. Preiss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w that to review of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the cholosate) to regardy man date of the Medical Device Amendments, or to devices that have been May 20, 1970, and chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that roomstitud in approval of a premarket approval application (PMA). You may, therefore, market the do not roquite approvisions of the Act. The general controls provisions of the Act active, subjoct to the general registration, 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 n your are ree subject to such additional controls. Existing major regulations affecting your Apploval), it the 70 be of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease be advisod that i Dr. I one device complies with other requirements of the Act or any I DA has made a decorninations administered by other Federal agencies. You must comply with all the I car a satues and regulations as annual in ited to registration and listing (21 CFR Part 807); labeling ACC STEQuirements, moduling, but novements as set forth in the quality systems (QS) (27 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting your interest of your device to a legally premarket nothication. The I DA miding of backannel.
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), please If you desire specific advice for your device 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 premaket notification the Also, please note the regulation entired, "Thiseration on your responsibilities under the Act from the 180 807.97). You may outain other general meanst on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
5
Page 1 of_1
510(k) Number (if known): 4041579
Device Name: Medela® Single Use Silc Cup
Indications For Use:
· Fetal distress in the second stage
• Maternal delay in the second stage
• Maternal conditions requiring a short second stage
The Medela® Obstetrical Vacuum Delivery System (Single Use Silc Cup) is a sterile, disposable I de Medita@ Obscerred. Tacation of the delivery of the fetus during childbirth. The device enables that the device miended to be ascu to the birth canal) by means of a suction cup attached to the traction to be applice to the team note (in isource and indicated for using during vaginal or cesarean delivery.
ﯿﮟ
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)
(Optional Format 3-10-98)
David b. Symm
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number