(82 days)
Not Found
Not Found
No
The device description focuses on mechanical components like needles, tubing, and valves, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to introduce or remove gametes, zygotes, preembryos, and/or embryos into or from the body, which is a procedural function, not a therapeutic one. Therapeutic devices are typically used for treatment or to cure a disease.
No
The device is used to introduce or remove gametes, zygotes, preembryos, and/or embryos into or from the body, which describes a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly details physical components such as needles, tubing, valves, and vials, indicating it is a hardware medical device.
Based on the provided information, this device is NOT an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "introduce or remove gametes, zygote(s), preembryo(s) and/or embryo(s) into or from the body." This describes a procedure performed on the body, not a test performed on a sample taken from the body to provide diagnostic information.
- Device Description: The device descriptions detail needles, catheters, and collection vials used for the physical process of retrieving or transferring biological material. There is no mention of reagents, assays, or any components used for analyzing a sample to diagnose a condition or provide information about a patient's health status.
- Lack of Diagnostic Information: The description does not mention any output or result that would be used for diagnostic purposes. The device facilitates a procedure, it doesn't analyze a sample to provide a diagnosis.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is used for a procedural purpose related to assisted reproduction.
N/A
Intended Use / Indications for Use
These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
Product codes
85 MQE
Device Description
H.O.C. Set™ Hazout oocyte collector with or without valve Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip Optional: 3-way valve
The device features a simple flux metallic needle, 30 cm in useful length, 17 gauge in outside diameter and 18 gauge in inside diameter, with double chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.
The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a 30 ml round-bottomed vial fitted with a screw-cap, or to a 30 ml round-bottomed vial fitted with a flexible cap (model HOC Set 2).
The model with a three-way valve set between the puncture needle and the collecting vial allows suction and rinsing of the follicles in turn.
Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. H.O.C. vials are also sold alone by 50 units.
O.P.S. Oocyte Puncture Set™ Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip
The device features a simple flux metallic needle, 30 cm in useful length and 17 gauge in outer diameter and 18 gauge in inside diameter, with doublechambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. The device must be connected to an irradiation sterilized Falcon tube.
The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a Falcon tube.
Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs.
Luer-lock Needle for Ovum recovery Needle: 25 cm or 30 cm; O.D. 17 gauge, echogenic tip; I.D. 18 gauge
Simple flux steel needle, 17 gauge in outside diameter and 18 gauge in inside diameter, with double-chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.
Two sizes: 25 cm or 30 cm long.
The needle has a Luer-lock to attach a syringe, and a green plastic inner madrel. The needle is placed in a Teflon packing tubing for protection. Packaging: Disposable device in single unit sealed bag. Irradiation sterilized. Available in 10 unit packs.
Function of Devices/Significant Physical Characteristics of Device:
Both the H.O.C. Set™ (Hazout oocyte collector, with or without a valve) and the O.P.S. Oocyte Puncture Set™ procedures achieve a safe and effective recovery of a maximum ova, eliminating the risks of traumatic handling of the ovum that would be detrimental to zona pellucida integrity, thus insuring optimal operating conditions for ovum conservation and better fertilization rate.
The Luer-lock Needle for ovum recovery acts as a laparscopic or ultrasonographic ovum recovery device (transvesical, transvaginal, periurethral or endovaginal).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guidance
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(K) Summary
March 9, 1999
- PRODIMED Laboratories c/o Washington Regulatory Services Randolph L. Cooke 23 Welisewitz Road Ringoes, NJ 08551 609-466-0510 Fax 609-466-4443
2) DEVICE NAME:
Proprietary Names:
HOC SET with valve HOC SET without valve HOC SET with valve - Soft plug HOC SET without valve - Soft plug
OPS without valve OPS with valve OPS double lumen
Luer Lock Needle 30 cm Luer Lock Needle 25 cm or any specified length
Common Name: Assisted Reproduction Needles
Classification Name: Assisted Reproduction catheters are classified as Class II at 21 CFR 884.6100. The product code is 85 MQE.
- IDENTIFICATION: These devies have been down classified FR Vol 63, No. 175 September 10, 1998. Effective date: October 13, 1998.
4) DESCRIPTION OF DEVICE:
H.O.C. Set™ Hazout oocyte collector with or without valve Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip Optional: 3-way valve
こ
The device features a simple flux metallic needle, 30 cm in useful length, 17 gauge in outside diameter and 18 gauge in inside diameter, with double
1
chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.
The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a 30 ml round-bottomed vial fitted with a screw-cap, or to a 30 ml round-bottomed vial fitted with a flexible cap (model HOC Set 2).
The model with a three-way valve set between the puncture needle and the collecting vial allows suction and rinsing of the follicles in turn.
Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs. H.O.C. vials are also sold alone by 50 units.
O.P.S. Oocyte Puncture Set™ Needle: 30 cm; O.D. 17 gauge, I.D. 18 gauge, echogenic tip
The device features a simple flux metallic needle, 30 cm in useful length and 17 gauge in outer diameter and 18 gauge in inside diameter, with doublechambered point and echogenic distal tip on two centimeters for easier ultrasound guidance. The device must be connected to an irradiation sterilized Falcon tube.
The needle is placed in a teflon packing tubing for protection. A teflon-cast catheter carries the aspirated follicular fluid to a Falcon tube.
Packaging: Disposable device in single unit blister packaging. Irradiation sterilized. Available in 5 unit packs.
Luer-lock Needle for Ovum recovery Needle: 25 cm or 30 cm; O.D. 17 gauge, echogenic tip; I.D. 18 gauge
Simple flux steel needle, 17 gauge in outside diameter and 18 gauge in inside diameter, with double-chambered point and echogenic distal tip on two centimeters for easier ultrasound guidance.
Two sizes: 25 cm or 30 cm long.
The needle has a Luer-lock to attach a syringe, and a green plastic inner madrel. The needle is placed in a Teflon packing tubing for protection. Packaging: Disposable device in single unit sealed bag. Irradiation sterilized. Available in 10 unit packs.
2
Function of Devices/Significant Physical Characteristics of Device:
Both the H.O.C. Set™ (Hazout oocyte collector, with or without a valve) and the O.P.S. Oocyte Puncture Set™ procedures achieve a safe and effective recovery of a maximum ova, eliminating the risks of traumatic handling of the ovum that would be detrimental to zona pellucida integrity, thus insuring optimal operating conditions for ovum conservation and better fertilization rate.
The Luer-lock Needle for ovum recovery acts as a laparscopic or ultrasonographic ovum recovery device (transvesical, transvaginal, periurethral or endovaginal).
Device Design/ Material Used/ Physical Properties:
| HOC SET: | |
|---|---|
| Device Part | Material Used |
| Needle | Metal |
| Fitting | Polyamide |
| Collect tube | |
| Vacuum tube | Polyether amide |
| Plug | Polyethylen |
| Tape | Polycarbonate |
| Collect ube | Butadien styren |
| OPS SET: | |
| Device Part | Material Used |
| Needle | Metal |
| Fitting | Polyamide |
| Collect tube | |
| Vacuum tube | Polyetreamid |
| Plug | |
| Tape | Polycarbonate |
| Luer-lock Needles: | |
| Device Part | Material Used |
| Needle | Metal |
| Fitting | Polyamide |
| Mandrel | Polyamide |
5) STATEMENT OF INTENDED USED
These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
3
HOC SET with valve HOC SET without valve HOC SET with valve – Soft plug HOC SET without valve – Soft plug
OPS without valve OPS with valve OPS double lumen
i
Luer Lock Needle 30 cm Luer Lock Needle 25 cm or any specified length
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
JUN 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PRODIMED Laboratories c/o Washington Regulatory Services Mr. Randolph L. Cooke 23 Welisewitz Road Ringoes, N.J. 08551
Re: K990913
PRODIMED Assisted Reproduction Needles Dated: March 11, 1999 Received: March 18, 1999 Regulatory Class: II 21 CFR §884.6100/Procode: 85 MQE
Dear Mr. Cooke:
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 pror 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 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 requlations affecting your device can be found in the Code of Federal Requlations. 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 requlation (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) 594-4613. 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 requilation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Qther 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,
[signature]
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
5
510(k) number (if known)_K990913
DEVICE NAME: Prodimed Assisted Reproduction Needles
INDICATIONS FOR USE:
These devices are used to introduce or remove gametres, zygotes(s), preembryo)s) and/or embryo(s) into or from the body.
HOC SET with valve HOC SET without valve HOC SET with valve - Soft plug HOC SET without valve - Soft plug
OPS without valve OPS with valve OPS double lumen
Luer Lock Needle 30 cm Luer Lock Needle 25 cm or any specified
(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 CFE 801.109
OR
Over-The Counter-Use_______ (Options Format 1-2-96)
Ra-Pales
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number