(38 days)
Not Found
Not Found
No
The 510(k) summary describes a sperm wash medium, a chemical reagent used in laboratory procedures, and contains no mention of AI or ML technology.
No
The device is described as "Sperm Wash Medium" used for "in vitro washing for IUI procedures, incubation and manipulation." This indicates it's a medium for handling sperm outside the body, not a device intended to treat a disease or condition in a patient.
No
The intended use describes the device as being used for "in vitro washing for IUI procedures, incubation and manipulation," which indicates a role in preparation or processing rather than diagnosis.
No
The device description and other sections are not found, but the intended use clearly describes a physical medium ("Sperm Wash Medium") used for in vitro procedures, indicating a physical substance, not software.
Based on the provided information, the device "Sperm Wash Medium" is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used for "in vitro washing for IUI procedures, incubation and manipulation." The term "in vitro" is a key indicator of an IVD. IVDs are used to examine specimens taken from the human body (in this case, sperm) outside of the body.
- Function: The function of washing, incubation, and manipulation of sperm for IUI (Intrauterine Insemination) is a process performed on a biological specimen in a laboratory or clinical setting to prepare it for a medical procedure. This aligns with the definition of an IVD.
While the other sections are "Not Found," the clear statement of "in vitro" use for a medical procedure is sufficient to classify this device as an IVD.
N/A
Intended Use / Indications for Use
Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Not Found
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
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
DEC 13 2002
Conception Technologies, L.P % Grace Holland, Regulatory Consultant Regulatory Specialists, Inc. 3722 Ave. Sausalito IRVINE CA 92606
Re: K023717
Trade/Device Name: Sperm Wash Medium & Sperm Wash Medium with Gentamicin Regulation Number: 21 CFR 884.6180 Regulation Name: Reproductive media and supplements
Regulatory Class: II
Product Code: 85 MQL Dated: November 4, 2002 Received: November 5, 2002
Dear Ms. Holland:
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.
1
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), 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
2
:
Indications for Use Statement
023717
1 . . . .
Page
. ·
| 510(k) Number (if known): | _____________________________________________________________________________________________________________________________________________________ |
|---|---|
| --------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------- |
Sperm Wash Medium Device Name:
Indications For Use:
Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.
(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, | |
| and Radiological Devices | |
| 510(k) Number | K023717 |
| Prescription Use
(Per 21 CFR 801.109) | | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | -------------------------------------------- | ---- | -------------------------------------------------- |
|---|
REGULATORY SPECIALISTS, INC.
3
Indications for Use Statement
Page : 1 of
510(k) Number (if known):
Device Name: Sperm Wash Medium with Gentamicin
Indications For Use:
Sperm Wash Medium is used for in vitro washing for IUI procedures, incubation and manipulation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elanid A. Seggern
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 0237 510(k) Number
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use (Optional Format 1-2-96)