(241 days)
Not Found
No
The device description details a purely optical system for viewing, with no mention of computational analysis, image processing, or any terms related to AI/ML.
No
The device is used for diagnostic and surgical procedures, providing direct viewing of organs. It does not actively treat or mitigate a disease or condition itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the laparoscopes are used for "performing diagnostic and surgical procedures."
No
The device description clearly details physical components like fiber optic imaging fibers, illumination fibers, a stainless steel jacket, a detachable light carrying cable, a distal lens, and an optical eyepiece, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- Device Function: The description clearly states that Saber's Rigid Fiber Optic Laparoscopes are used for direct viewing of organs within the peritoneal cavity for diagnostic and surgical procedures. This is an in vivo (within the living body) procedure.
- Intended Use: The intended use is for direct visualization inside the body, not for testing samples taken from the body.
Therefore, based on the provided information, this device falls under the category of a surgical or diagnostic instrument used inside the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Saber's Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
Not Found
Device Description
Saber Endoscopy's Rigid Fiber Optic Laparoscopes are small diameter endoscopes which consist of fiber optic imaging fibers and illumination fibers contained within a stainless steel jacket. Light from a high intensity light source is transmitted to the scope by a detachable light carrying cable. The light is then carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the image fiber bundle. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an optical eyepiece. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
peritoneal cavity
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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
K944079, K950278, K921883, K926597
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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FEB - 7 1997
1962246 Ploy2
510(k) Summary: #K962246
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- Submitter: Saber Endoscopy, L.L.C. 6191 Atlantic Blvd., Suite 5 Norcross. GA 30071
- Contact: Dr. Ronald J. Ehmsen (714) 771-7656
November 14, 1996 Date Prepared:
- Name of Device: Rigid Fiber Optic Laparoscope 2) (Not yet determined) Proprietary/Trade Name: Common/Usual Name: Laparoscope Class II (21 CFR §884.1720) Classification: Classification Name: Laparoscope, Gynecologic
3) Name of Predicate or Legally Marketed Devices:
Saber's Rigid Fiber Optic Laparoscopes are substantially equivalent to the following predicate devices:
- Imagyn Medical, Inc. ● MicroLap™ Laparoscope Approved by FDA for marketing on 20-Jan-95 under 510(k) # K944079.
- Olympus America, Inc. . Mini Laparoscope for General Surgery Approved by FDA for marketing on 01-Feb-95 under 510(k) #K950278.
- Optimed Technologies, Inc. ● OptiMIS® Series 300 Rigid Fiber Optic Laparoscopes Approved by FDA for marketing on 23-Nov-92 under 510(k) #K921883 for abdominal laparoscopy and other indicated uses, and on 12-Jul-94 under 510(k) #K926597 for gynecologic laparoscopy.
4) Description of Device:
Saber Endoscopy's Rigid Fiber Optic Laparoscopes are small diameter endoscopes which consist of fiber optic imaging fibers and illumination fibers contained within a stainless steel jacket. Light from a high intensity light source is transmitted to the scope by a detachable light carrying cable. The light is then carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the image fiber bundle. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an optical eyepiece. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.
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510(k) Summary: #K962246 Saber Endoscopy, L.L.C. Rigid Fiber Optic Laparoscopes November 14, 1996 Page 2
ર) Intended Use of Device:
Saber's Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Comparison of Technological Characteristics: 6)
Saber's Rigid Fiber Optic Laparoscopes are substantially equivalent' to the predicate or legally marketed Imagyn MicroLap Laparoscope, Olympus Mini Laparoscope for General Surgery, and Optimed Series 300 Rigid Fiber Optic Saber's scopes employ the same design considerations and Laparoscopes. operating principles as the predicate devices, and each can be sterilized and Any differences between the Saber, Imagyn, Olympus and Optimed reused. laparoscopes do not raise new questions regarding safety or effectiveness.
'The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.