(149 days)
Used to obtain oocytes from the body
The Single Lumen Sideport Needle is intended to obtain gametes from the body. The catalog number is GNSP-732.
The basic design is a single stainless steel needle tubing of 32 cm in exposed length, with a grounded point. It is attached to a hub of polycarbonate designed especially for this purpose. The outer diameter of the outer needle tube maybe 16 or 17gauge, 17 being more desirable.
Attached to the hub are two lengths of tubing. One is attached to the rear of the needles, which allows the occytes to be aspirated into a collection test tube, and the second length is attached to the flush port on the side. This second port is attached to a syringe, which allows the operator to inject media into the follicle to allow "flushing"
This document is a 510(k) Premarket Notification for a medical device, the Single Lumen Sideport Needle. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through studies that meet specific acceptance criteria as you've outlined. Therefore, much of the information you requested regarding acceptance criteria, study details, and performance metrics is not typically present in this kind of regulatory filing.
Here's what can be inferred and what cannot be provided based on the given text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device and adherence to general controls and special controls (though specific special controls aren't detailed, only that they exist for assisted reproduction needles).
- Reported Device Performance: Not provided in terms of quantitative clinical or analytical performance. The document describes the device's intended use and design but does not report on its performance against specific clinical outcomes or statistical targets.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. There is no mention of a "test set" in the context of a performance study with human subjects or analytical samples. This is a premarket notification based on substantial equivalence.
- Data Provenance: Not applicable. No performance data from clinical or analytical studies is presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. There is no mention of a "test set" requiring ground truth established by experts.
4. Adjudication Method for the Test Set:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study would be used to assess the effectiveness of the device in a clinical setting, often comparing human performance with and without an AI-assisted device. This document does not describe such a study.
6. Standalone Performance Study (Algorithm Only):
- No, a standalone performance study was not done. The device described is a physical medical instrument (needle) and does not involve an algorithm.
7. Type of Ground Truth Used:
- Not applicable. There is no test set or performance study where ground truth would be established.
8. Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set," as this device is a physical instrument, not an AI or software algorithm that would require training data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
Key Information from the Document (Relevant to Substantial Equivalence):
- Device Name: Single Lumen Sideport Needle
- Classification Name: Assisted Reproduction Needle
- Intended Use: "Used to obtain oocytes from the body"
- Design: Single stainless steel needle tubing (32 cm exposed length, grounded point, 16 or 17 gauge), polycarbonate hub, two tubing lengths (one for aspiration, one for flushing).
- Sterilization: Gamma Irradiated (2.5 Mrad, SAL: 10^-6) in accordance with ANSI / AAMI / ISO 11137-1994 Standards.
- Predicate Devices: The submission claims substantial equivalence to "several products currently marketed in the US." (Details expected in Section 2, which is not provided here).
- Regulatory Status: Cleared through 510(k) as Class II device, Procode 85 MQE, CFR# 884.6100.
In summary, the provided text is a 510(k) summary, which is a premarket notification for substantial equivalence, not a report on an efficacy or effectiveness study. Therefore, the specific details requested about acceptance criteria and study design are not found within this type of document.
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SEP g 1999
international. Inc. 510(K) Premarket Notification
510K Summary
- a) DEVICE NAME Proprietary Name: Single Lumen Sideport Needle
Classification Name: Assisted Reproduction Needle
ESTABLISHMENT REGISTRATION No.: 9003605 b)
international. Inc. 170 Fort Path Road Madison, CT 06443 Tel: 203-245-4901 Fax: 203-245-4994
Contact Individual: Michael D. Cecchi President
- CLASSIFICATION: Class II C) Assisted reproduction needles Product: Single Lumen Needle with Sideport Procode: 85 MQE CFR#: 884.6100
- PERFORMANCE STANDARDS d) Performance Standards under Section 514 of the ACT have not been developed for this device. However, Special controls have been identified by the FDA to provide reasonable assurance of safety and effectiveness of the device in assisted reproductive procedures.
- PROPOSED LABELS, LABELING, AND ADVERTISING e) The proposed labeling and instruction material is included in this package in the appropriate section.
- f) DESCRIPTION
The Single Lumen Sideport Needle is intended to obtain gametes from the body. The catalog number is GNSP-732.
The basic design is a single stainless steel needle tubing of 32 cm in exposed length, with a grounded point. It is attached to a hub of polycarbonate designed especially for this purpose. The outer diameter of the outer needle tube maybe 16 or 17gauge, 17 being more desirable.
Attached to the hub are two lengths of tubing. One is attached to the rear of the needles, which allows the occytes to be aspirated into a collection test tube, and the second length is attached to the flush port on the side. This second port is
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attached to a syringe, which allows the operator to inject media into the follicle to allow "flushing"
- SUBSTANTIALLY EQUIVALENT g) The Single Lumen Sideport Needle is substantially equivalent to several products currently marketed in the US. See the appropriate section for the comparisons. (Section 2)
h) STERILIZATION PROCEDURES AND FACILITIES
All needles manufactured, will be Gamma Irradiated by and according to the guidelines in place.
Dosage: 2.5 Mrad Sterility Assurance Level (SAL): of (10 to the -6 ) After sterilization the contractor will issue a "Certificate of Sterilization".
Validation assurance is in accordance with ANSI / AAMI / ISO 11137-1994 Standards.
See Section 11.0
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 9 1999
Mr. Michael D. Cecchi President International, Inc. 170 Fort Path Road, Unit 14 Madison, CT 06443
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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act indude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
Re: K991264
Single Lumen Sideport Needle
21 CFR §884.6100/Procode: 85 MQE
Dated: June 10, 1999
Regulatory Class: II
Received: June 22, 1999
If your device is classified (see above) into either 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 requlations.
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) 594-4613. 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 requlation 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. 510(K) Premarket Notification
Response #2
Re: K991264 Single Lumen Sideport Needle
INDICATIONS FOR USE
510 (k) Number ( if known )___________________________________________________________________________________________________________________________________________________
Device Names: Single Lumen Sideport Needle Indication for Use:
.
"Used to obtain oocytes from the body"
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Concurrence of CDRH, Office of Device Evaluation ( ODE )
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K991264 |
|---|---|
| --------------- | --------- |
| Prescription Use | |
|---|---|
| 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).