(71 days)
Not Found
No
The device description and other sections do not mention any AI or ML capabilities. The device is a simple catheter for sperm transfer.
Yes
Explanation: The device is used for intrauterine insemination, which is a medical procedure to assist reproduction. While it's a device for transferring sperm, its ultimate purpose is therapeutic (to help achieve pregnancy).
No
The device is used for transferring sperm into the uterine cavity for intrauterine insemination, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly describes a physical catheter made of Polypropylene, which is a hardware component. There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The described device is a catheter used to transfer sperm directly into the uterine cavity. This is a procedure performed within the body (in vivo). It is a delivery device, not a diagnostic testing device.
The description clearly indicates its purpose is for a medical procedure (intrauterine insemination) and not for analyzing biological samples to diagnose or monitor a condition.
N/A
Intended Use / Indications for Use
The Insemination Catheters are used for transferring sperms into the uterine cavity.
The catheter is used for intrauterine insemination.
Product codes (comma separated list FDA assigned to the subject device)
85 MQF, 85 MFD
Device Description
The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine cavity
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K910577, K980061, K972823, K982628, K914150
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).
0
K021438
Page 1 of 2
Labotect Insemination Catheter 320301: abbreviated 510(k)submission
JUL 1 6 2002
Summary of Safety and Effectiveness
Submitted By:
Angelika Albrecht c/o Labotect GmbH Willi-Eichler-Str. 25 37079 Göttingen Germany Telephone number: 01149 551 505010 Fax number: 01149 551 5050111
Date 2002-05-01
Device:
Trade Name: Proposed Classification Name: Insemination Catheter Assisted Reproduction Catheters Class II 85 MQF
Predicate Devices:
Edwards-Wallace Bourne-Hall (K910577) Marlow-Surgical
Embryon Intra-uterine Insemination Catheters (K980061) Rocket Medical
Mini-Embryon Intra Uterine Insemination Catheter (K972823) A&A Medical, Inc.
MedWorks Insemination Catheter (K982628) MedWorks Corp.
Jansen-Anderson Insemination Set (K914150) Cook OB/Gyn
Device description and intended use:
The Insemination Catheters are used for transferring sperms into the uterine cavity. They have a well rounded tip and two distal side ports. The insemination fluid is introduced using a syringe attached to the proximal luer. The material used in these devices is Polypropylene. Biocompatibility is assured according to ISO 10993.
1
KO2/438
Page 2 of 2
Special Controls:
These insemination catheters are manufactured and marketed according to special controls of 21CFR Sec. 884.6110.
-
Mouse Embryo Assay batch tested: Two-Cell-MEA, blastocyst hatching >80%
-
Endotoxin batch tested: Bacterial Endotoxin Assay, Endotoxin Value The Labelling meets the requirements of 21 CFR Part 801 and Part 884. special controls
- A Biocompatibility was tested according to Blue Book memorandum #G95-1 entitled " Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing." The devices are tested on cytotoxicity, sensitization and irritation or intracoutaneous reactivity using GLP methods.
-
Clinical application is evaluated using a "Post-Marketing-Surveillance-System" to collect and analyse data from clinical application. These Insemination Catheters are marketed for more than 10 years in the EU without any adverse events.
Substantial Equivalence:
The Insemination Catheters are substantially equivalent to the predicate devices with respect to the indications for use, design and performance specifications.
Conclusion:
Based on indications for use, technological characteristics, and comparison to currently marketed insemination catheters, the Labotect-Insemination Catheter has been shown to be safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
等意義的意義。因為有人權為在國家的意義的意義。因為為國國家會在在有意義的意義
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
THE PRODUCTION CONSTITUTION
Food and Drug Administration 9200 Corporate Boulevard
Rockville MD 20850
JUL 1 6 2002
Ms. Angelika Albrecht Quality Manager Labotect GmbH Labor-Technik-Göttingen Willi-Eichler-StraBe 25 D-37079 Göttingen GERMANY
Re: K021438 Trade/Device Name: Insemination Catheter, Model 320301 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 MFD Dated: June 19, 2002 Received: July 5, 2002
Dear Ms. Albrecht:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined 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 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) 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 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 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 FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your 510(k) preinarket 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the 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 http://www.fda.gov/cdrh/dsma/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
4
| 510(k) Number (if known): | K021438 |
|---|---|
| Device Name: | Insemination Catheter |
Indications For Use:
2744,55
The catheter is used for intrauterine insemination.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Form) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K021438510(k) Number _
nal Format 1-2-96)