(71 days)
Not Found
Not Found
No
The device description is purely mechanical and there are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is used for irrigation/aspiration during eye surgery, which is a procedural function rather than directly treating a disease or condition. While it aids in a surgical procedure, it does not itself provide a therapeutic effect.
No
Explanation: The device is described for "irrigation/aspiration during eye surgery," which are therapeutic or procedural functions, not diagnostic ones. It does not mention any capability to diagnose or detect medical conditions.
No
The device description clearly states it consists of a stainless steel needle, plastic luer lock, and silastic tubing, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For irrigation/aspiration during eye surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a needle with a soft tip designed for physical manipulation (irrigation and aspiration) within the eye.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform such a function.
Therefore, this device falls under the category of a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For irrigation/aspiration during eye surgery.
Product codes
HMX
Device Description
The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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
§ 886.4350 Manual ophthalmic surgical instrument.
(a)
Identification. A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
0
Image /page/0/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo features a large letter A in a white square, followed by a series of vertical lines in a black rectangle. To the right of these shapes, the words "AMERICAN MEDICAL DEVICES, Inc." are stacked in three lines. The text is in a bold, sans-serif font.
1100 Northside Drive Atlanta, Georgia 30318
MAY 20 1997
में बनाने के बाद में बाद में बाद में बाद में कि में बाद में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला में कि महिला
X970873
Page 1 Summary
February 26, 1997
{
Premarket Notification [510(k)] Summary
Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 30318 Phone: (404) 815-5233 (404) 815-5235 Fax:
Official Correspondent: Frank J. Tighe
Trade Name: The American Medical Devices, Inc., 19 and 20 Ga. Endosoft™ Soft Tip Needles
Common Name: Irrigation/Aspiration Needle
Registration Number: We have registered but have not received our application back as of this date.
Class: Class 1
Class Name: We were unable to find the device listed in the classification
11 - 1 - 1 - 1 - 1 - 1 - 12 - 2007 97 - 1 Class fons, 21 CFR Parts 862-892 [807.87 (c)].
Panel: Ophthalmic
Product Code: HMX
| Toll-Free | Direct | Facsimile | Internet |
|---|---|---|---|
| 800-793-1473 | 404-815-5233 | 404-815-5235 | ftighe@americanmedicaldevices.com |
1
Device Description: The American Medical Devices, Inc 19 and 20 ga. Endosoft™ Soft Tip Needles are for irrigation/aspiration during eye surgery. The device consists of a stainless steel needle with a plastic luer lock on one end and a protruding piece of soft silastic tubing at the tip. This device connects to any conventional extrusion handpiece with a male luer lock adapter.
Statement of indications for use. - For irrigation during eye surgery.
Substantial Equivalence Comparison
| | American Medical
Devices, Inc. | Visitec | Grieshaber |
|--------------------------------------------------------------------|-----------------------------------|---------|------------|
| Packaging
Tyvek to Poly | X | X | X |
| For irrigation/aspiration
Of the eye during surgery | X | X | X |
| Materials: Stainless Steel Needle,
Silastic Tubing, Plastic Hub | X | X | X |
| Sterilization ETO | X | X | X |
Sterility
The Device will be ETO Sterilized.
The method used to validate the sterilization cycle is AAMI Overkill Method
Packaging Material: Tyvek Pouch with a Ploymylar Sheath.
The SAL is 10 to the -6.
The maximum levels of residues of ethylene oxide: 25 parts per million, ethylene chlorohydrin: 25 parts per million and ethylene glycol: 250 parts per million.
This device is non-pyrogenic and the LAL Method is used to make that determination.
Pyrogens: We control the manufacturing environment to lessen the likelihood of pyrogen causing bacteria. In addition the LAL Method is used to determine that each lot is non-pyrogenic.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 1997
Mr. Frank J. Tighe Offical Correspondent American Medical Devies, Inc. `1100 Northside Drive Atlanta, GA 30318
Re: K970873 · Trade Name: Endosoft™ Soft Tip Needle (19 GA. and 20 GA.) Regulatory Class: I Product Code: 86 HMX Dated: February 26, 1997 Received: March 10, 1997
Dear Mr. Tighe:
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 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 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 dovice 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.
3
Page 2 - Mr. Frank J. Tighe
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 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 at (301) 443-6597.
Sincerely yours,
Alseph L. Rienthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1100 Northside Drive Atlanta, Georgia 30318
(510(k) Number (if known): K970873
Device Name: Endosoft™ Soft Tip Needle (19 GA. and 20 GA.)
Indications For Use:
For irrigation/aspiration during eye surgery
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
William Hoang
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number
5970873
| Prescription Use X (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ----------------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
,