(58 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a needle and tubing set, with no mention of AI or ML capabilities.
No.
The device is used for the retrieval of oocytes, which is a diagnostic or procedural step in assisted conception, rather than treating a disease or condition.
No
The device is used for the physical collection of oocytes (a recovery and collection procedure), not for diagnosing a condition or disease.
No
The device description clearly describes a physical needle and tubing, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical collection of oocytes from ovarian follicles using ultrasound guidance. This is a procedural device used in vivo (within the body) to retrieve biological material.
- Device Description: The description details a needle and tubing designed for a surgical/procedural purpose – puncturing and aspirating.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze the collected oocytes or any other biological sample to provide diagnostic information about a patient's condition. IVDs are used to examine specimens in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
The device is a tool for a medical procedure (oocyte retrieval), not a diagnostic test.
N/A
Intended Use / Indications for Use
The device is for ultrasound guided transvaginal recovery and collection of oocytes from ovarian follicles.
Product codes
MQE
Device Description
The oocyte recovery needles are single use sterile devices provided for ultrasound guided transvaginal collection and recovery of oocytes from ovarian follicles for use during assisted conception procedures. The set consist of a single lumen, stainless steel needle attached to tubine. The needle is 33 cm in length and available in 16 Ga. or 17 Ga. Each device has 2 cm of echogenic markings at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. The tubing is attached to the proximal end of the needle and protrudes a total distance of 90 cm until it terminates in a silicone bung.
The subject devices will be packaged in a flexible pouch composed of Tyvek heat sealed to polyethylene film. The pouch is designed to be peeled open. The pouch will be placed in a white carton box. Each carton will contain 10 units. The subject devices will be sterilized using Ethylene Oxide using SAL 10°.
The two versions to be offered are: 16 Ga. (AR-N1695) and 17 Ga. (AR-N1795).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
ovarian follicles
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)
The subject device has been subject to biocompatibility testing (for the materials that contact that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 884.6100 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
FDA 510(k) Premarket Notification CooperSurgical Oocyte Recovery Needles
510 (k) Summarv
JAN 2 2 2003
Date Prepared [21 CFR 807.92(a)(1)]
November 22, 2002
Submitter's Information [21 CFR 807.92(a)(1)}
Joseph M. Azary C/o CooperSurgical Inc. 543 Long Hill Avenue Shelton, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor CooperSurgical Inc., 95 Corporate Drive, Trumbull, CT 06611.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade names are: CooperSurgical Oocyte Recovery Needles Common Name: Assisted Reproduction Needles
Predicate Device [21 CFR 807.92(a)(3)]
SIMS Portex, Wallace Oocyte Retrieval Set - K012068
The subject devices have the same indications for use, material composition, sterilization method, and working dimensions. The main difference is the luer of the subject device is slightly larger (both in diameter and length) than the predicate device and the subject device has a needle hub composed of ABS instead of methyl pentene.
Description of the Device [21 CFR 807.92(a)(4)}
The oocyte recovery needles are single use sterile devices provided for ultrasound guided transvaginal collection and recovery of oocytes from ovarian follicles for use during assisted conception procedures. The set consist of a single lumen, stainless steel needle attached to tubine. The needle is 33 cm in length and available in 16 Ga. or 17 Ga. Each device has 2 cm of echogenic markings at the distal tip for ultrasound reflection and a plastic hub at the proximal end for ease of guidance by hand. The tubing is attached to the proximal end of the needle and protrudes a total distance of 90 cm until it terminates in a silicone bung.
The subject devices will be packaged in a flexible pouch composed of Tyvek heat sealed to polyethylene film. The pouch is designed to be peeled open. The pouch will be placed in a white carton box. Each carton will contain 10 units. The subject devices will be sterilized using Ethylene Oxide using SAL 10°.
The two versions to be offered are: 16 Ga. (AR-N1695) and 17 Ga. (AR-N1795).
1
| Component | Material | Details |
|---|---|---|
| Needle Hub | ABS (Acrylonitrile Butadiene | |
| Styrene) | Bayer Lustran 266 ABS | |
| Needle | Stainless Steel | 304 Stainless Steel |
| Needle Guard | Polyethylene | No patient contact |
| Stopper | Silicone | Dow Corning Material Q7-4840 |
| Luer | Polypropylene | Montellprofax 6323 Compounded |
| by Chroma with PMS 240 U Pink. | ||
| Large OD Tubing | Polyurethane | Pellethane 2363-90A R0120 Poly- |
| urethane | ||
| Small OD Tubing | Polyurethane | Pellethane 2363-90A R0120 Poly- |
| urethane | ||
| Small Sleeve | Silicone | Dow Corning Material Q7-4840 |
| Tip Protector | Polyethylene | No patient contact |
The subject devices are composed of the following materials:
Intended Use [21 CFR 807.92(a)(5)}
The device is for ultrasound guided transvaginal recovery and collection of occytes from ovarian follicles.
Technological Characteristics [21 CFR 807.92(a)(6)]
CooperSurgical Inc. believes that the subject device is substantially equivalent to the predicate device. The subject device is composed of the same materials, sterilized using the same method, complies with the same standards, has the same indications for use, and is similar dimensionally. There are minor differences with the packaging, outer diameter and length of the Luer, and the material of the needle hub.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subject to biocompatibility testing (for the materials that contact that is equivalent to ISO 10993-1 Biocompatibility requirements. The subject device also complies with ISO 594-1 1986 Conical fittings with a 6% (luer) taper requirements.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2003
CooperSurgical, Inc. % Mr. Joseph M. Azary Manager AZARY Technologies, LLC P.O. Box 2156 HUNTINGTON CT 06484
Re: K023930
Trade/Device Name: CooperSurgical Oocyte Recovery Needles Regulation Number: 21 CFR 884.6100 Regulation Name: Assisted reproduction needles Regulatory Class: II Product Code: 85 MQE Dated: November 22, 2002 Received: November 25, 2002
Dear Mr. Azary:
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.
3
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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
4
5 10(k) Number (if known): _ KO23930
Device Name: CooperSurgical Inc. Oocyte Recovery Needles
Indications For Use: The device is for ultrasound guided transvaginal recovery and collection of oocytes from ovarian follicles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
David A. Lynn
(Division Sian-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Page 4 510(k) CooperSurgical Oocyte Recovery Needle