(93 days)
Aesculap's Sovercign® mini system is indicated for use in adult and pediatric diagnostic and therapcutic general endoscopy and laparoscopy surgery.
Aesculap's Sovereign® mini system can be used in adult and pediatric laparoscopic general surgery. The system consists of modular forceps and scissors in lengths of 200 and 290 millimeters with interchangeable ratcheting and non-ratcheting handles. The system also includes reusable trocars and trocar pins. The trocars and trocar pins are available in 3.5 millimeter diameter and 60 and 110 millimeter lengths, and 5 millimeter and 60,110 and 150 millimeter lengths with or without a stopcock. The 3.5mm trocars are for use with the 3.5mm instruments, and the 5mm trocars accommodate 4 and 5mm endoscopes. The instruments and trocars are composed of stainless steel and PEEK materials.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria based on performance data.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No Performance Data or Acceptance Criteria: The document explicitly states under the "PERFORMANCE DATA" section that "No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices." This indicates that there are no specific, quantitative performance criteria or studies for this device outlined in this submission.
- Focus on Substantial Equivalence: The primary purpose of this 510(k) submission is to demonstrate "Substantial Equivalence" to a predicate device (Aesculap Needlescopic Instrument System K982623). The comparison focuses on "TECHNOLOGICAL CHARACTERISTICS" such as design, size, materials, and monopolar capabilities, rather than on new performance data against set acceptance criteria.
Therefore, the following information cannot be provided from the given text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: No test set or performance data is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth or expert review is discussed for performance.
- Adjudication method for the test set: No test set is mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a surgical instrument, not an AI-assisted diagnostic tool, so such a study would not be applicable and is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical instrument.
- The type of ground truth used: Not applicable, as performance data against a ground truth is not provided.
- The sample size for the training set: Not applicable, as this is not a learning algorithm.
- How the ground truth for the training set was established: Not applicable.
Summary from the provided documents:
The submission focuses on the Sovereign® mini system being substantially equivalent to the Aesculap Needlescopic Instrument System (K982623).
- The device is a Laparoscope, General and Plastic Surgery instrument (Endoscope and Accessories).
- It is intended for adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.
- The modified instruments are stated to have the same technological characteristics as the predicate devices, being similar in design, size, manufacturing materials, and monopolar capabilities.
- No specific performance standards or performance data are provided in this regulatory submission for the modified device.
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K123102 Page 1 of 2
B. Special 510(k) Summary (as required by 21 CFR 807.92)
| Sovereign® mini SystemSeptember 28, 2012 | JAN 0 3 2013 | |
|---|---|---|
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714 | |
| CONTACT: | Denise R. Adams610-984-9076610-791-6882 (fax)denise.adams@aesculap.com | |
| COMMON NAME: | Laparoscope, General and Plastic Surgery | |
| CLASSIFICATION NAME: | Endoscope and Accessories | |
| REGULATION NUMBER: | 21 CFR 876.1500 | |
| PRODUCT CODE: | GCJ | |
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the modified components of the Sovereign® mini system are substantially equivalent to the components of the Aesculap Needlescopic Instrument System (K982623).
DEVICE DESCRIPTION
Aesculap's Sovereign® mini system can be used in adult and pediatric laparoscopic general surgery. The system consists of modular forceps and scissors in lengths of 200 and 290 millimeters with interchangeable ratcheting and non-ratcheting handles. The system also includes reusable trocars and trocar pins. The trocars and trocar pins are available in 3.5 millimeter diameter and 60 and 110 millimeter lengths, and 5 millimeter and 60,110 and 150 millimeter lengths with or without a stopcock. The 3.5mm trocars are for use with the 3.5mm instruments, and the 5mm trocars accommodate 4 and 5mm endoscopes. The instruments and trocars are composed of stainless steel and PEEK materials.
INDICATIONS FOR USE
Aesculap's Sovereign® mini system is indicated for use in adult and pediatric diagnostic and therapeutic general endoscopy and laparoscopy surgery.
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Page 2 of 2
ರ
TECHNOLOGICAL CHARACTERISTICS
The modified instruments have the same technological characteristics as the predicate devices. They are similar in design and size, manufactured from the same materials, and have monopolar capabilities. .
PERFORMANCE DATA
No applicable performance standards have been promulgated under Section 514 of the Food, Drug, and Cosmetic Act for these devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the top half of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Aesculap, Incorporated % Ms. Denise Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034
January 3, 2012
· Re: K123102
Trade/Device Name: Aesculap Sovereign® mini System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 01, 2012 Received: December 04, 2012
Dear Ms. Adams:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Denise Adams
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT . A.
510(k) Number:_K123102
Device Name: Aesculap Sovereign® mini System
Indications for Use:
Aesculap's Sovercign® mini system is indicated for use in adult and pediatric diagnostic and therapcutic general endoscopy and laparoscopy surgery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X = and/or Over-the-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwight Yen 2013.01.02 15:52:57 -05'00'
(Division Sign-Off) Division of Surgical Devices 510(k) Number ___K123102
§ 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.