(149 days)
The Single Lumen Needle is intended to obtain oocytes from the body.
The Single Lumen Needle is intended to obtain oocytes from the body. All needles manufactured, will be Gamma Irradiated and or steam sterilized by and in accordance to the guidelines in place.
This document is a 510(k) summary for the Single Lumen Needle, submitted by International, Inc. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, this document does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The 510(k) process for medical devices primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical or analytical studies in the same way a Premarket Approval (PMA) would.
Therefore, I cannot provide the requested information from the provided text for the following reasons:
- No Acceptance Criteria: The document does not specify any quantitative acceptance criteria for the Single Lumen Needle's performance (e.g., success rate of oocyte retrieval, material strength, biocompatibility metrics, etc.).
- No Performance Study: There is no mention of a study (clinical or analytical) designed to demonstrate the device meets any specific performance criteria. The submission focuses on substantial equivalence based on device description, intended use, and manufacturing processes (gamma irradiation/steam sterilization).
- No Standalone or MRMC Study: Since no performance study is described, there's no data to report on standalone performance or a multi-reader multi-case comparative effectiveness study.
- No Ground Truth Information: Without a performance study, there's no ground truth defined, no expert consensus, or sample sizes for test or training sets mentioned.
The document states:
- "No Performance Standards have been developed by Food and Drug Administration under Section 514 of the Act for this device."
- "This product is substantially equivalent to several product currently sold in the market."
The FDA's letter confirms: "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..." This means the device was approved based on its similarity to existing devices, not on new performance data against specific acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the text "SEP 9 1999". The text is in a simple, sans-serif font. The letters and numbers are black against a white background.
Image /page/0/Picture/1 description: The image shows the logo for Gen X International. The logo consists of the text "genX" enclosed in angle brackets. Below the logo is the word "international" in a smaller font size. The logo is simple and modern, and the use of angle brackets gives it a tech-savvy feel.
170 Fort Path Road, Madison, CT 06443 203-245-4994 FAX 800-966-6453
510K Summarv
KG91262
- Device Name: Propriety Name: Single Lumen Needle
Classification: Reproductive Media
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- Submission Date: Submission Date: March 26, 1999
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- Submitted by:
international, Inc. 170 Fort Path Road Madison, CT 06443
Establishment Registration No .: 9003605
Tel: 203-245-4901 Fax: 203-245-4994 E-mail:genxintl@aol.com
Contact Individual: Michael D. Cecchi President
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- Classification: Class II Assisted Reproductive Needles Product: Single lumen Needle Procode: 85 MQE CFR#: 884.6100
- ട്. Performance Standards:
No Performance Standards have been developed by Food and Drug Administration under Section 514 of the Act for this device. However, certain Special Controls have been identified in order to provide reasonable assurance of the safety and effectiveness of the device used in assisted reproduction procedures.
- ଚ. Proposed labels, Labeling and Advertising: The product labeling is included in this application in the appropriate section.
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- Substantially Equivalence Comparison This product is substantially equivalent to several product currently sold in the market See Section 2.0 for this data.
- Device Description, Intended Use 8.
The Single Lumen Needle is intended to obtain oocytes from the body.
- All needles manufactured, will be Gamma Irradiated and or steam sterilized by 9. and in accordance to the guidelines in place. See Section 11.0
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a bold, sans-serif font. The text is arranged on a single line, with each word clearly visible. The overall impression is clean and professional.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP g 1999
Mr. Michael D. Cecchi President International, Inc. 170 Fort Path Road, Unit 14 Madison, CT 06443
Re: K991262 Single Lumen Needle Dated: June 5, 1999 Received: June 18, 1999 Requlatory Class: II 21 CFR §884.6100/Procode: 85 MQE
Dear Mr. Cecchi:
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 fer 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 III (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 Compilance 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/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting 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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international, inc.
Re: K991262 Sperm Washing Media
Response to #2
510(K) Premarket Notification
INDICATION FOR USE
510 (k) Number ( if known ) K991262
Device Names: single Lumen Needle
Indication for Use:
"Used to obtain oocytes from the body"
(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 | K9912162 |
|---|---|
| --------------- | ---------- |
| Prescription Use | X | or | Over-the Counter Use |
|---|---|---|---|
| ------------------ | ------------------------------------------------------- | ---- | ---------------------- |
§ 884.6100 Assisted reproduction needles.
(a)
Identification. Assisted reproduction needles are devices used in in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures to obtain gametes from the body or introduce gametes, zygote(s), preembryo(s) and/or embryo(s) into the body. This generic type of device may include a single or double lumen needle and component parts, including needle guides, such as those used with ultrasound.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing).