ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)

K970882 · American Medical Devices, Inc. · MPA · Jun 24, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970882
• Device Name: ENDOLIGHT END IRRIGATING ENDO-ILLUMINATOR (20 GA. AND 19 GA.)
• Applicant: American Medical Devices, Inc.
• Product Code: MPA · Gastroenterology, Urology
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For illumination and irrigation/aspiration during surgery.

Device Story

Endolight™ End Irrigating Endo-Illuminator is a surgical instrument used for simultaneous illumination and irrigation/aspiration during ophthalmic surgery. The device consists of a stainless steel needle, delrin handpiece, PMMA fiberoptic fiber with plastic cladding, aluminum connector, and silastic tubing with a luer lock connector. It connects to a conventional light source via an accessory adapter and to a standard syringe for fluid management. Operated by a surgeon in a clinical/surgical setting, the device provides localized light and fluid control to the surgical site, facilitating visualization and tissue manipulation. The device is provided sterile via ETO sterilization.

Clinical Evidence

Bench testing only. Sterilization validation performed using AAMI Overkill Method; SAL 10^-6 achieved. Non-pyrogenicity confirmed via LAL method. No clinical data provided.

Technological Characteristics

Materials: stainless steel needle, delrin handpiece, PMMA fiberoptic fiber, aluminum connector, silastic tubing. Sterilization: ETO (AAMI Overkill Method). Connectivity: connects to external light source via adapter and standard syringe via luer lock. Form factor: 19 and 20 gauge needle.

Indications for Use

Indicated for illumination and irrigation/aspiration during surgery. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Gamp & Assoc (not specified)
• Grieshaber (not specified)
• Infinitech (not specified)

Submission Summary (Full Text)

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K970882.
JUN 24 1997

1100 Northside Drive Atlanta, Georgia 30318

February 27, 1997

# Premarket Notification [510(k)] Summary

**Submitter:** American Medical Devices, Inc
1100 Northside Drive
Atlanta, GA 30318
Phone: [phone]
Fax: [phone]

**Official Correspondent:** Frank J. Tighe

**Trade Name:** The American Medical Devices, Inc., 19 and 20 Ga. Endolight™ End Irrigating Endo-Illuminator.

**Common Name:** Fiberoptic End Irrigating Endo-Illuminator

**Registration Number:** We have registered but have not received our application back as of this date.

**Class:** Class II

**Class Name:** We were unable to find the device listed in the classification regulations, 21 CFR Parts 862-892 [807.87 (c)].

**Panel:** Ophthalmic

**Product Code:** MPA

Page 1 Summary

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| 793-1473 | 404-815-5233 | 404-815-5235 | [e-mail] |

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Device Description: The American Medical Devices, Inc 19 and 20 ga. Endolight™ End Irrigating Endo-Illuminators are for illumination and irrigation/aspiration during surgery. It consists of a stainless steel needle, delrin handpiece, PMMA fiberoptic fiber with plastic cladding, aluminum connector, and silastic tubing with luer lock connector. It connects to any conventional light source via an aluminum accessory adapter, which is packaged separately. This device also connects to any standard syringe with a male luer lock. The surgeon can then use the device to irrigate and aspirate while illuminating. Please see Device Replica Diagram in Appendix C.

Statement of indications for use. - For illumination and irrigation/aspiration during surgery.

Substantial Equivalence Comparison

| | American Medical Devices, Inc. | Gamp & Assoc | Grieshaber | Infinitech |
| --- | --- | --- | --- | --- |
| Packaging
Tyvek to Poly | X | X | X | X |
| For irrigation/illumination
During surgery | X | X | X | X |
| Materials: Stainless Steel Needle,
PMMA Fiberoptic Fiber, Delrin
Handpiece, Luer Lock Connector,
Silastic Tubing | X | X | X | X |
| Aluminum Connector | X | X | X | X |
| Sterilization ETO | X | 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.

Page 2 Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 24 1997

Mr. Frank J. Tighe
American Medical Devices, Inc.
1100 Northside Dr.
Atlanta, GA 30318

Re: K970882
Trade Name: Endolight™ End Irrigating
Endo-Illuminator (19 and 20 GA.)
Regulatory Class: II
Product Code: 86 MPA
Dated: June 9, 1997
Received: June 13, 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 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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K970882

AMD

AMERICAN

MEDICAL

DEVICES, Inc.

1100 Northside Drive Atlanta, Georgia 30318

(510(k) Number (if known): K970882

Device Name: Endolight™ End Irrigating Endo-Illuminator (19 and 20 Ga.)

Indications for Use:

For illumination and irrigation/aspiration during surgery.

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 CFR 801.109)

OR


(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K970882

Over-The-Counter Use
(Optional Format 1-7-96)

| Ill-Free | Direct | Facsimile | Internet |
| --- | --- | --- | --- |
| 793-1473 | 404-815-5233 | 404-815-5235 | [e-mail] |