(311 days)
Not Found
Not Found
No
The device description and performance studies indicate a chemical indicator, not a software-based system utilizing AI/ML. There are no mentions of AI, ML, image processing, or training/test sets.
No
The device is a pH indicator used in culture dishes, not for direct therapeutic use on patients. Its purpose is to monitor CO2/pH levels, not to treat or diagnose a disease.
No
The device is described as a visual CO2/pH indicator for culture dishes/incubators, used for CO2/pH control, not for diagnosing a medical condition in a patient.
No
The device description explicitly states it is a bicarbonate-buffered pH-indicator containing Phenol Red, which is a chemical substance, not software.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use: The intended use is "For visual CO2/pH control." While it explicitly states "Not for culture," the purpose is to monitor conditions within a culture environment (specifically mentioned as "in the culture dish or incubator"). This monitoring of the environment where biological samples (like embryos in assisted reproduction) are being handled is a key characteristic of IVDs used in laboratory settings.
- Device Description: It's a "bicarbonate-buffered pH-indicator containing Phenol Red." This is a chemical reagent designed to react with the environment (CO2/pH) and provide a visual signal. Reagents used to analyze or monitor biological processes or environments are common IVDs.
- Intended User / Care Setting: "Assisted reproduction facilities" are clinical laboratory settings where biological samples are handled and processed. This is a typical environment for the use of IVDs.
- Performance Studies: The mention of the Limulus Amebocyte Lysate (LAL) Assay, which is used to test for toxins, is a quality control measure often applied to reagents and materials used in sensitive biological applications, including those involving human samples.
- Predicate Device(s): The comparison to the category of "Reproductive Media (21 C.F.R. § 884.61800)" is a strong indicator. Reproductive media are typically classified as IVDs because they are used in the in vitro handling and manipulation of human gametes and embryos. While this device isn't the culture media itself, its function is directly related to monitoring the environment of that media.
In summary, the device is a reagent used to monitor the environment of biological samples in a clinical laboratory setting (assisted reproduction facilities). This aligns well with the definition and characteristics of an In Vitro Diagnostic device.
The fact that it's "Not for culture" simply means it's not the media in which the cells or embryos are grown, but rather a tool to assess the conditions of that environment.
N/A
Intended Use / Indications for Use
pH™-100 is intended to be used as a visual indicator for CO»/pHcontrol in the culture dish or incubator. It is not intended for the preparation or culture of cells.
For visual CO2/pH control. Not for culture.
Product codes (comma separated list FDA assigned to the subject device)
85 MQL
Device Description
pH™100 is a bicarbonate-buffered pH-indicator containing Phenol Red. It is used as a visual CO2/pH indicator in the culture dish or incubator. Readyto-use after equilibrium at +37 °C and 5% CO2. pH™-100 includes Penicillin-G as a preservative.
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.
Substantial equivalence established by comparison to category of Reproductive Media (21 C.F.R. § 884.61800) as provided in the FDA's Notice of Final Rule. 63 Fed. Reg. 48428, 48430 (Sept. 10. 1998)
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
K991346 Page 1 of 2
FEB 2 4 2000
PREMARKET NOTIFICATION SUMMARY
| Submitted by: | Scandinavian IVF Sciences AB
Mölndalsvägen 30
SE-412 63 Gothenberg
SWEDEN |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. Eiler Anderson
Vitrolife AB
Mölndalsvägen 30
SE-412 63 Gothenberg
SWEDEN
Tele: +46 31 721 80 00
Fax: +46 31 721 80 99 |
| Date Prepared: | April 16, 1999 |
| Trade Name: | pH TM-100 |
| Common Name: | Assisted Reproduction Media |
| Classification Name: | Reproductive Media and Supplements
(21 C.F.R. § 884.6180) |
| Predicate Device: | Substantial equivalence established by comparison to
category of Reproductive Media (21 C.F.R. §
884.61800) as provided in the FDA's Notice of Final
Rule. 63 Fed. Reg. 48428, 48430 (Sept. 10. 1998) |
Description of the Device:
pH™100 is a bicarbonate-buffered pH-indicator containing Phenol Red. It is used as a visual CO2/pH indicator in the culture dish or incubator. Readyto-use after equilibrium at +37 °C and 5% CO2. pH™-100 includes Penicillin-G as a preservative.
Intended Use:
pH™-100 is intended to be used as a visual indicator for CO»/pHcontrol in the culture dish or incubator. It is not intended for the preparation or culture of cells.
Technological Characteristics:
1
The technological characteristics of pH™-100 are identical to other legally marketed media classified under 21 C.F.R. § 884.6180, Reproductive Media and Supplements.
Testing Performed:
Prior to and as a condition for market release, each lot of pHTM-100 is assayed by Limulus Amebocyte Lysate (LAL) Assay. This assay is intended to assure that the media does not contain unacceptable levels of toxins. Information on the assay is provided in the labeling of the products and on a LOT-specific Certificate of Analysis provided with each delivery.
The Mouse Embryo Assay is not performed on pH™-100 because the composition of the product is neither intended for nor compatible with embryo development.
pH™-100 has been used for CO2/pH control during culture for many years at many different assisted reproduction facilities. Clinical experience during that time has established its safety and effectiveness for such use.
50054096.2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2000
Scandinavian IVF Sciences AB c/o Mr. Gary L. Yingling McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Re: K991346
pH™ -100, Assisted Reproduction Media Dated: November 30, 1999 Received: November 30, 1999 Requiatory Class: Il 21 CFR $884.6180/Procode: 85 MQL
Dear Mr. Yingling:
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 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. 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 (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 (QS) 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) 594-4591. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
VIII. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
pH™ -100 Assisted Reproduction Media
Indications For Use:
For visual CO2/pH control. Not for culture.
David C. Segrom
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 C.F.R. § 801.109)
OR
Over-the Counter Use_