(30 days)
No
The summary describes a purely mechanical surgical instrument with no mention of computational processing, algorithms, or data analysis.
No
This device is described as a surgical instrument for grasping, mobilizing, dissecting, transecting, and suturing tissue, which are actions performed during a surgical procedure, not for treating or curing a medical condition.
No
Explanation: The device is described as an instrument for surgical procedures like grasping, dissection, and suturing, not for identifying a disease or condition. Its function is to perform actions on tissue, not to diagnose.
No
The device description clearly states it is a physical instrument with a handle, jaws, and shaft, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures (grasping, mobilization, dissection, transection, suturing of tissue) under direct and endoscopic visualization. This involves interacting directly with the patient's body during a surgical procedure.
- Device Description: The description details a surgical instrument with a handle, jaws, shaft, and articulating sections, designed for use through incisions or trocars. This is consistent with a surgical tool, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are typically used in laboratories or point-of-care settings to diagnose diseases or conditions by testing samples.
Therefore, the RealHand™ High Dexterity (HD) Instruments are surgical instruments used in vivo (within the living body) and do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.
Product codes
GCJ
Device Description
The RealHand Instruments are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissor blades) are activated by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place, a rotation control wheel and articulation lock.
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)
Product testing was conducted to evaluate conformance to product specification. Testing included grasping, manipulating, cutting and suturing of tissue.
Testing comparing the RealHand Instruments to a commercially available predicate product was conducted. The products were used per their respective Instructions for Use. The results showed the RealHand Instruments were equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
JUN 29 2007
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | RealHand TM High Dexterity (HD) Instruments. |
| Submitter | Novare Surgical Systems, Inc. |
| 10440 Bubb Road | |
| Suite A | |
| Cupertino, CA 95014 | |
| Tel: 408-873-3161 | |
| Contact | Kerry Pope |
| President & CEO |
Intended Use
The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.
Predicate Devices
Endolink TM True Movement System™ K043541 Novare Surgical Systems, Inc.
Device Description
The RealHand Instruments are single use, sterile instruments that consist of a handle, jaws, and a shaft which includes distal and proximal articulating sections. The instruments are similar in size to other instruments and are designed for use through an incision or appropriately sized surgical trocars/ports. The instrument jaws (or scissor blades) are activated by compressing and releasing the handle. The handle can include a ratchet and ratchet release which allow the instrument jaws to be locked in place, a rotation control wheel and articulation lock.
1
Materials
All materials used in the manufacture of the RealHand Instruments are suitable for this use and have been used in numerous previously cleared products.
Testing
Product testing was conducted to evaluate conformance to product specification. Testing included grasping, manipulating, cutting and suturing of tissue.
Testing comparing the RealHand Instruments to a commercially available predicate product was conducted. The products were used per their respective Instructions for Use. The results showed the RealHand Instruments were equivalent to the predicate device.
Summary of Substantial Equivalence
The RealHand Instruments are equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, framing the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Novare Surgical Systems % Regulatory Strategies, Inc. Mr. Gregory Mathison President 3924 Cascade Beach Road Lutsen, Minnesota 55612
Re: K071488
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: May 24, 2007 Received: May 30, 2007
Dear Mr. Mathison:
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. Gregory Mathison
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 vours.
Anastacia M. Bilek
Image /page/3/Picture/5 description: The image shows a handwritten letter. The letter is written in cursive and the text is not fully visible. The visible text includes the letters 'for' on the left side of the image, followed by the words 'Director' and 'Director' on the right side of the image. The letter appears to be a formal document.
ം Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
This application
Device Name:
Indications for Use:
RealHand™ High Dexterity (HD) Instruments
The RealHand™ High Dexterity (HD) Instruments are intended for grasping, mobilization, dissection, transection and / or suturing of tissue under direct and endoscopic visualization.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
X Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use (Optional Format 1-2-96)
Anastasia M. Bilek
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
OR
510(k) Number K071488
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