(21 days)
Not Found
No
The summary describes a mechanical instrument with an added electroconductive pathway. There is no mention of AI or ML capabilities, data processing, or algorithms.
Yes
The device is intended for medical procedures like grasping, dissection, suturing, and electrocautery of tissue, which are actions performed to treat or diagnose conditions.
No
The device description and intended use focus on surgical manipulation of tissue (grasping, mobilization, dissection, transection, suturing, electrocautery) rather than diagnosing medical conditions.
No
The device description clearly details physical modifications to existing instruments, including the addition of a post and an internal jumper, indicating it is a hardware device with added functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for manipulating tissue within the body ("grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization"). This is an in vivo (within a living organism) application.
- Device Description: The description focuses on the physical modifications to the instrument itself, specifically related to adding an electroconductive pathway for electrocautery. This is consistent with a surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples outside the body (e.g., blood, urine, tissue samples) to diagnose a condition or provide information about a patient's health status. IVDs are typically used in laboratories or point-of-care settings for analysis of biological specimens.
Therefore, the RealHand™ High Dexterity (HD) instruments are surgical instruments, not IVDs.
N/A
Intended Use / Indications for Use
The RealHand™ High Dexterity (HD) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
A new electroconductive pathway was added. This change consists of two basic modifications to the existing instruments: 1) a post was added to attach a third party generator via an insulated commercially available legally marketed cable. 2) an internal jumper was added to conduct current from the post to the internal shaft of the instrument. The substantial equivalence of the changes are based on a comparison of physical and functional attributes of the device contrasted with the Novare predicate and the indications of the Pajunk instruments.
The place of manufacture has not changed. The physical appearance of the device, though slightly different, does not adversely affect the modified device. Functional expectations, material suitability, surgical technique and indications for use are just the same as the comparison devices placed in product code GCI by FDA.
RealHand™ High Dexterity Instruments are substantially equivalent to the original instruments with respect to functionality and performance characteristics based the following criteria:
-
RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical.
-
The RealHand™ High Dexterity Instruments were carefully evaluated and compared with the original Novare device. Documented testing established that the characteristics are equal to the original.
-
The original device was evaluated for proper function during use. The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent, and
-
the RealHand™ High Dexterity Instruments worked as intended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent to the original device.
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.
K071488, K043541, K033249, K984240
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
§ 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.
0
NOVARE SURGICAL SYSTEMS, INC ummary of Safety Information SEPTEMBER 19, 2007 emarket Notification, Section 510(k) Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority: Ko72715 RealHand High Dexterity (HD) Instruments Device Name: Common Name(s): Endoscopic instruments Classification Name(s): Endoscope and Accessories 007 16 2007 Manufacturer: Novare Surgical Systems, Inc. 2954739 Reg. Number: 10440 Bubb Road, Suite A Address: Cupertino, CA 95014 Classification(s): Sec. 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 cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescope lamps, biliary pancreatoscopes. proctoscopes. resectoscopes. nephroscopes, sigmoidoscopes. ureteroscones. 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 classifications in other parts of the device classification regulations.
(b) Classification. (1) Class II (performance standards).
(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.
[48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996,
| Device Class: | Class II for the requested indications |
|---|---|
| Classification Panel: | Gastroenterology & Urology |
| Product Code(s): | GCJ |
Equivalent Predicate Device:
Novare Surgical Systems, Inc. believes that the modified RealHand™ High Dexterity Instruments are substantially equivalent to the following legally marketed device:
1
- Endolink "RealHand" Articulating Instruments, K071488 Novare Surgical Systems, Inc., and . Endolink "True Movement" Articulating Instruments, K043541 - Novare Surgical Systems, Inc.
- Pajunk Modular Handled Instruments, K033249 .
- . Endopath Endoscopic Instruments, K984240
Device Description:
A new electroconductive pathway was added. This change consists of two basic modifications to the existing instruments: 1) a post was added to attach a third party generator via an insulated commercially available legally marketed cable. 2) an internal jumper was added to conduct current from the post to the internal shaft of the instrument. The substantial equivalence of the changes are based on a comparison of physical and functional attributes of the device contrasted with the Novare predicate and the indications of the Pajunk instruments.
The place of manufacture has not changed. The physical appearance of the device, though slightly different, does not adversely affect the modified device. Functional expectations, material suitability, surgical technique and indications for use are just the same as the comparison devices placed in product code GCI by FDA.
RealHand™ High Dexterity Instruments are substantially equivalent to the original instruments with respect to functionality and performance characteristics based the following criteria:
-
RealHand™ High Dexterity Instruments provide hemostatic clamping that allows electrocautery and ligature of tissue. The performance of the systems are essentially identical.
-
The RealHand™ High Dexterity Instruments were carefully evaluated and compared with the original Novare device. Documented testing established that the characteristics are equal to the original.
-
The original device was evaluated for proper function during use. The modified RealHand™ High Dexterity Instruments were evaluated using a valid test methodology, including electrocautery function and the test result was equivalent, and
-
the RealHand™ High Dexterity Instruments worked as intended.
Company Contact:
Mr. David Danitz Novare Surgical Systems, Inc. 10440 Bubb Road. Suite A Cupertino, CA 95014 408.873.3161
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2007
Novare Surgical Systems, Inc % Buckman Company, Inc Mr. David w. Schlerf Vice President 1070 Concord Avenue, Suite 230 Concord, California 94520
Re: K072715
Trade/Device Name: RealHand™ High Dexterity (HD) Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 19, 2007 Received: September 25, 2007
Dear Mr. Schlerf:
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.
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.
3
Page 2 - Mr. David w. Schlerf
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
مع
Mark N. Melkerson
Director
16
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Page 3 – Mr. David w. Schlerf
cc: HFZ-401 DMC HFZ-401 Divic
HFZ-404 510(k) Staff HFZ-410 DGRND/GSDB D.O. . . . D.O.
f/t:RPW:kxl:10-04-07 2017 2017 2017 2014 07 2016 10 :RPW:kxl:10-04-07
and the comments of the comments of the comments of
.
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
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510(k) Number :_ | צורגרס | צ
Page _ 1 _ _ _ _ of of
RealHandTM High Dexterity (HD) Instruments Device Name(s):
Indications for Use Statement(s):
The RealHand™ High Dexterity (HD) instruments are intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.
Prescription Use -------X OR Over-The-Counter Use PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Rela R
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K072715
(Per 21 CFR 801.109)
(Optional format 1-2-96)
Cautery2.Doc
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