(84 days)
K number not provided in text
Not Found
No
The summary describes a traditional optical laparoscope with no mention of AI/ML features or image processing capabilities.
No
The device is a microlaparoscope used for visualization and manipulation during surgical procedures; it does not directly treat or prevent a medical condition, but rather aids in diagnosis and surgical intervention.
Yes
The device is indicated for use in "diagnostic and operative surgical procedures" and in specific gynecological laparoscopy indications such as "Diagnosis and/or treatment of ectopic pregnancy" and "Determination of the presence and extent of pelvic endometriosis". These directly relate to diagnosing conditions.
No
The device description explicitly states it is a rigid rodlens optical design and transfers light via glass fiber optics, indicating it is a hardware device.
Based on the provided information, the Dyonics 2.7mm Microlaparoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Function: The Dyonics 2.7mm Microlaparoscope is a surgical instrument used inside the body (in vivo) to provide visualization and access during surgical procedures. It directly interacts with body cavities and organs.
- Intended Use: The intended use clearly describes its use in surgical procedures for visualization and manipulation within the body. There is no mention of analyzing samples taken from the body.
Therefore, the Dyonics 2.7mm Microlaparoscope falls under the category of a surgical endoscope or laparoscope, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.
For use in gynecological laparoscopy the following specific indications apply:
- Unexplained pelvic pain (acute, chronic)
- Infertility work-up
- Tubal sterilization
- Diagnosis and/or treatment of ectopic pregnancy
- Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)
- Evaluation of congenital anomalies of the pelvic organs
- Retrieval of foreign bodies
- Determination of the presence and extent of pelvic endometriosis
- Determination of the presence and extent of pelvic inflammatory disease (if not in acute stage)
- Access to abdomen for surgical procedures such as LAVH
- Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) organs
Product codes (comma separated list FDA assigned to the subject device)
85 HET
Device Description
The Smith & Nephew Dyonics 2.7mm Microlaparoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities, hollow organs and canals, pelvic organs, abdomen, abdominal (pelvic) organs
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The Richard Wolf Medical 2.0mm mini laparoscope. (K number not provided in text)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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SEP 1 0 1998
510(k) Summary Smith & Nephew, Inc., Endoscopy Division Dyonics 2.7mm Microlaparoscope
Substantial Equivalence:
The Smith & Nephew Dyonics 2.7mm Microlaparoscope is substantially equivalent in design, materials, function, and intended use to the Richard Wolf Medical 2.0mm mini laparoscope.
Predicate Device:
The predicate device for this submission is the Richard Wolf Medical 2.0mm mini laparoscope.
Summary of Device Function:
The Smith & Nephew Dyonics 2.7mm Microlaparoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a rigid rodlens optical design.
Intended Use of Device:
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.
For use in gynecological laparoscopy the following specific indications apply:
- Unexplained pelvic pain (acute, chronic) ●
- Infertility work-up ●
- Tubal sterilization ●
- Diagnosis and/or treatment of ectopic pregnancy ●
- Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma . (less than 16 weeks gestational size)
- Evaluation of congenital anomalies of the pelvic organs
- . Retrieval of foreign bodies
- . Determination of the presence and extent of pelvic endometriosis
- Determination of the presence and extent of pelvic inflammatory disease . (if not in acute stage)
- Access to abdomen for surgical procedures such as LAVH .
- Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs
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Comparison of Technological Characteristics of Predicate Device:
The basic technologies, design and function of the Smith & Nephew Dyonics 2.7mm Microlaparoscope is substantially equivalent in materials, design and function to the Richard Wolf Medical 2.0mm mini laparoscope.
Welsh J. Coman
Deborah J. Connors Sr. Regulatory Affairs Specialist
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features the department's seal, which includes an emblem of three stylized human profiles facing right, arranged in a stacked formation. The words "DEPARTMENT OF HEALTH & HU..." are arranged in a circular fashion around the emblem.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10 1998
Ms. Deborah J. Connors Senior Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, MA 01810
Re: K982149 Dyonics 2.7mm Microlaparoscope Dated: August 27, 1998 Received: August 28, 1998
21 CFR 884.1720/Procode: 85 HET
Regulatory Class: II
Dear Ms. Connors:
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 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 (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 equivaliance 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 OS 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%) 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmamain.html", -
Sincerely vours
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K982149 510(k) Number :
Device Name : Smith & Nephew, Inc., Endoscopy Division Dyonics Microlaparoscope
Indications for Use :
The Dyonics 2.7mm Microlaparoscope is indicated for use in general laparoscopy and gynecological laparoscopy to provide access, illumination and allow visualization or manipulation of body cavities, hollow organs and canals during diagnostic and operative surgical procedures.
For use in gynecological laparoscopy the following specific indications apply:
- Unexplained pelvic pain (acute, chronic) .
- Infertility work-up ●
- . Tubal sterilization
- Diagnosis and/or treatment of ectopic pregnancy .
- . Evaluation, diagnosis and/or treatment of pelvic tumors, including myoma (less than 16 weeks gestational size)
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C. Szyrm
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices Devices
510(k) Number K982149
ption Use OR Over-the-Counter
Prescription Use V (Per 21 CFR 801.109) Over-the-Counter _____________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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For use in gynecological laparoscopy the following specific indications apply: (cont'd)
- Evaluation of congenital anomalies of the pelvic organs .
- . Retrieval of foreign bodies
- Determination of the presence and extent of pelvic endometriosis .
- Determination of the presence and extent of pelvic inflammatory disease (if . not in acute stage)
- Access to abdomen for surgical procedures such as LAVH .
- Visualization, diagnosis and/or treatment of perforated abdominal (pelvic) . organs