(210 days)
No
The device description and intended use are for a simple, disposable needle for anesthetic administration. There is no mention of any computational or analytical capabilities, let alone AI/ML.
Yes
The device is used for injection and administration of anesthetic regional blocks, which is a therapeutic intervention to manage pain.
No
The device is described as an "anesthetic needle" used for "injection and administration of anesthetic regional blocks," which indicates a therapeutic rather than a diagnostic function.
No
The device description clearly states the device is a physical needle made of stainless steel, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Gynex Extended Reach Needles are described as instruments for injection and administration of anesthetic regional blocks directly into the body (paracervical, uterosacral, and pudendal areas). They are used during medical procedures (labor, delivery, minor surgery).
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the body. The device's function is to deliver a substance (anesthetic) into the body.
Therefore, the device's purpose and mechanism of action clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
-
- Iniection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
-
- Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.
Product codes
85HEE
Device Description
The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5100 Obstetric anesthesia set.
(a)
Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.(b)
Classification. Class II (performance standards).
0
1103
ed Reach Needle arv of Safety and s Information Notification. Section 510(k)
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
1. Device Name:
Trade Name: Gynex Extended Reach Needle . Disposable Needle, disposable anesthetic needle Common Name: Classification Name: Obstetric anesthesia set & accessories
2. Establishment Name & Registration Number:
GYNEX Corporation Name: . Number: 3032109
3. Classification:
$ 884.5100 Obstetric anesthesia set. (a) Identification. An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both. (b) Classification. Class II (performance standards).
4. Establishment Name & Registration Number:
Name: GYNEX Corporation Number: 3032109
5. Classification:
Device Class: Class II Classification Panel: Ob/Gyn Devices Panel Product Code: 85HEE
6. Preamendments Device:
-
- Pudendal and paracervical block anesthesia instruments, Gynecology, Obstetrics, V. Mueller, The Surgical Armamentarium, 1973., pp. 219
7. Equivalent Legally Marketed Device(s):
-
- Potocky Needle Disposable Injection Needle, K910252, Cooper Surgical.
..
- Potocky Needle Disposable Injection Needle, K910252, Cooper Surgical.
1
P293
8. Device Description:
The Gynex Extended Reach Needles are made of 302 instrument grade stainless steel. There are two styles each being 27 gauge and 90mm in length. One is equipped with a standard I hore are the other basing thas a threaded hub. Both are disposable. As is typical for this type of anesthetic needle, the shaft of the needle is dual diameter. That is, the shaft of the needle from the hub to within 5mm of the tip a is larger diameter. This allows for easy estimation of insertion depth during anesthetic administration and prevents over-insertion of needle into deeper tissue levels or spaces.
Applicant Name & Address: 9.
GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052
Company Contact: 10.
Mr. Steve Angelo, President GYNEX Corporation 16700 NE 79th St., Suite 204 Redmond, WA 98052 425.882.1179 * 425.895.0115 - fax
11. Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 1000 Burnett Av.. Suite 450 Concord, CA 94520 510.356.2640 - 510.356.2654 - fax
12. Comparison Table:
| FEATURE | Gynex Extended Reach Needle | Pudendal/Paracervical Needle &
Potocky Needle | SE? |
|----------------------------|------------------------------------------------|-------------------------------------------------------------------------|------------|
| Indications for
Use(s): | Administer Paracervical pudendal
anesthetic | Administer Paracervical pudendal
anesthetic | YES |
| Design: | Leuer lock & threaded hub | Leuer lock | YES |
| Sterilization
Method: | Radiation - Supplied sterile -
disposable | Steam Autoclave - reusable
Potocky -Supplied sterile -
disposable | NO&
YES |
| Sizes: | 90mm w/ 5mm 27 gauge tip | 6-8 inches - 20-25 gauge
Potocky - 90mm, 27 gauge | YES |
| Material: | 302 Stainless steel | 302 Stainless Steel | YES |
| Country of
Origin :: | Asia - Germany | Germany
Potocky - Asia - Germany | YES |
| Manufacturer: | Gynex Corporation | V. Mueller, Cooper Surgical | YES |
| Product Code: | 84HEE | 84HEE | YES |
| K - Number: | Pending | Preamendment & K910252
respectively | YES |
2
P3093
13. Voluntary Standards:
United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, GYNEX Corporation. Standard Operating Procedures (SOP), vendor certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.
14. Storage, Packaging & Sterilization Information:
The Gynex Iris/Angle Extended Reach Needles are supplied sterile and non-pyrogenic.
All needles are individually packaged & labeled and supplied in multi-unit packages and boxes for ease in shipping and storage. All packaging should be inspected on arrival for evidence of shipping damage. Damaged packaging may indicate the presence of unsafe product and it should not be used until carefully inspected. Any shipping damaged product may not be sterile and should be returned promotiv. Product for use in the operating room must be processed, opened, handled and placed into use following accepted operating room sterile technique.
Sterility Assurance Level (SAL) is at least 10°. A minimum of 2.5 Mrrad radiation exposure is The product is dosemetry released. The product is also non-pyrogenic. Vendor utilized. certification and secondary sampling is performed and documented.
3
Image /page/3/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized symbol with three curved lines resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUM" is partially visible, arranged vertically along the left side of the symbol. The image is in black and white.
AUG 21 1998
Gynex Corporation c/o Mr. David Schlerf Buckman Company, Inc. 200 Gregorv Lane, Suite C-100 Pleasant Hill, CA 94523-3389
9200 Corporate Boulevard Rockville MD 20850
Food and Drug Administration
Re: K980238
GYNEX Extended Reach Needle Dated: June 20, 1998 Received: August 4, 1998 Regulatory Class: II 21 CFR 884.5100/Procode: 85 HEE
Dear Mr. Schlerf:
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 devices marketed in intersiate 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 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 (OS) 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 80 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 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1
510(k) Number (if known): __ K 980236
Device Name(s):
GYNEX Extended Reach Needles
Intended Use:
-
- Iniection and administration of anesthetic regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.
-
- Injection and administration of anesthetic regional blocks (e.q., paracervical, uterosacral, and pudendal) that may be used during minor surgical procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Sothin
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K980238
OR
Prescription Use X
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional format 1-2-96)
GYNEX-EXTEND.doc