(85 days)
Not Found
No
The device description and performance studies focus on the mechanical and optical components of the endoscope and holding arm, with no mention of AI/ML capabilities or image processing.
No.
The device is used for access and observation during diagnostic and therapeutic procedures, but it does not perform a therapeutic function itself. It is an endoscope and a holding arm for visualization.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures." The term "diagnostic procedures" directly indicates its use for diagnosis.
No
The device description explicitly details physical components such as a rigid endoscope, flexible holding arm, optic, and light fiber, indicating it is a hardware device.
Based on the provided information, the SightFix is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery." This describes a device used in vivo (within the living body) for visualization during surgical procedures.
- Device Description: The description details a rigid endoscope with optics and light fibers, a holding arm, and compatibility with cameras and light sources. This aligns with the components of a surgical endoscope used for direct visualization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the living body) to provide diagnostic information. IVDs typically involve reagents, assays, or analysis of biological samples.
Therefore, the SightFix is a surgical visualization device, not an IVD.
N/A
Intended Use / Indications for Use
The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.
Product codes
GCJ
Device Description
The SightFix consists of a rigid endoscope and a flexible holding arm. The rigid endoscope of the SightFix contains an optic and a light fiber. The SightFix endoscope is designed to be used with the camera SightCam and the light source SightLight manufactured by WORLD OF MEDICINE Lemke GmbH. In addition, the use of adapters allows an easy attachment of standard 180W endoscopic light sources (halogen, xenon, quartz) to the endoscope. The holding arm of the SightFix is a manually operated endoscope holder to ensure an optimal positioning of the endoscope. Both the rigid endoscope and some components of the holding arm are autoclavable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities
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
The device complies with the International standards IEC 60601-2-18:1996 (Particular requirements for the safety of endoscopic equipment). Some Components of the SightFix comply with the European Standards EN 554:1994, EN 556:2001-01 and EN 1174-1:1996 (Sterilization of Medical Devices). In addition, the device bears the CE mark in accordance with the European Medical Device Directive 93/42/EEC.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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510(K) SUMMARY SightFix
MAR 1 8 2003
I. Submitter:
WORLD OF MEDICINE Lemke GmbH Danziger Strasse 21 82194 Gröbenzell Germany
II. Device Names:
- 1 . Classification Name: Endoscope and Accessory
-
- Common or Usual Name: Laparoscope and Endoscope Holder
-
- Proprietary Name:
SightFix
III. Classification:
Class II. The device is described in 21 C.F.R. § 876.1500. The product code for the device is GCJ.
IV. Predicate Device:
- MGB LAPALUX Telescope (K982013) manufactured by MGB Endoskopische . Geräte GmbH
- Robotrac ™ Retractor Arm (Unitrac) (K893121) manufactured by Aesculap Instruments Corp.
- KSEA Endoscope Holder (K990334) manufactured by Karl Storz Endoscopy-● America, Inc.
V. Intended Use:
The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.
VI. Device Description:
The SightFix consists of a rigid endoscope and a flexible holding arm. The rigid endoscope of the SightFix contains an optic and a light fiber. The SightFix endoscope is designed to be used with the camera SightCam and the light source SightLight manufactured by WORLD OF MEDICINE Lemke GmbH. In addition, the use of adapters allows an easy attachment of standard 180W endoscopic light sources (halogen, xenon, quartz) to the endoscope. The holding arm of the SightFix is a manually operated endoscope holder to ensure an optimal positioning of the endoscope. Both the rigid endoscope and some components of the holding arm are autoclavable.
1
VII. Substantial Equivalence:
The SightFix described in this notification is similar in intended use, design, material and technological characteristics to the MGB LAPALUX Telescope (K982013) manufactured by MGB Endoskopische Geräte GmbH, the Robotrac TM Retractor Arm (Unitrac) (K893121) manufactured by Aesculap Instruments Corp. and the KSEA Endoscope Holder (K990334) manufactured by Karl Storz Endoscopy-America, Inc.
Both the endoscope of the SightFix and the predicate device MGB LAPALUX Telescope (K982013) are intended to allow access and observation of body cavities during diagnostic and therapeutic procedures in laparoscopy. In addition, both devices are rigid and autoclavable.
The holding arm of the SightFix and the predicate devices Robotrac ™ Retractor Arm (Unitrac) (K893121) and KSEA Endoscope Holder (K990334) are devices all intended to hold an endoscope during diagnostic and therapeutic endoscopic procedures. Moreover, the SightFix holding arm and the Robotrac TM Retractor Arm (Unitrac) (K893121) are both intended to be used during open surgery. All three devices contain stainless steel and aluminum and can be sterilized.
The differences between the SightFix and the predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, WORLD OF MEDICINE Lemke GmbH believes that the SightFix is substantially equivalent to the predicate devices currently on the market.
VIII. Performance Data:
The device complies with the International standards IEC 60601-2-18:1996 (Particular requirements for the safety of endoscopic equipment). Some Components of the SightFix comply with the European Standards EN 554:1994, EN 556:2001-01 and EN 1174-1:1996 (Sterilization of Medical Devices). In addition, the device bears the CE mark in accordance with the European Medical Device Directive 93/42/EEC.
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Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three overlapping profiles, suggesting a sense of community or interconnectedness. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2003
World of Medicine Lemke GmbH c/o Ms. Susanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138
Re: K024251
Trade/Device Name: SightFix Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 13, 2002 Received: December 23, 2002
Dear Ms. Raab:
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. Iisting 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 such 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.
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Page 2 - Ms. Susanne Raab
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 (301) 594-4659. 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,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
.
| APPLICANT: | WORLD OF MEDICINE Lemke GmbH |
|---|---|
| 510(K) NUMBER (if known): | K024251 |
| DEVICE NAME: | SightFix |
INDICATIONS FOR USE:
The SightFix is intended to allow access and observation of body cavities and the surgical field during diagnostic and therapeutic procedures in laparoscopy and open surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 C.F.R. § 801.109)
(Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurologicas Devices
510(k) Number K024251