(81 days)
Not Found
No
The device description focuses on mechanical and pneumatic components, and there are no mentions of AI, ML, or related concepts in the provided text.
No.
The device is a surgical arm used for holding and manipulating surgical instruments, not directly treating a disease or condition.
No
The device is described as a surgical holding and manipulating arm, not a device used to diagnose medical conditions or diseases. Its function is to hold instruments during surgery.
No
The device description explicitly details physical components like an articulated arm, instrument holder, compressed gas supply, ball joints, and a control lever, indicating it is a hardware device.
Based on the provided information, the SAPHLIFT is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the SAPHLIFT is a "holding and manipulating arm for use in surgery." This describes a device used during a surgical procedure to assist the operating team with physical manipulation of instruments.
- Device Description: The description details a mechanical and pneumatic system for holding and positioning surgical instruments. It does not mention any components or functions related to testing samples from the human body (like blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Reagents or assays.
- Diagnostic or screening purposes.
- Measurement of biomarkers or analytes.
The SAPHLIFT is a surgical accessory designed to facilitate surgical procedures, not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand.
Product codes (comma separated list FDA assigned to the subject device)
MDW, GCJ
Device Description
The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.
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)
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.
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
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
3/30/99
510(k) Summary for SAPHLIFT
K90062
- SPONSOR
:ぐ
Genzyme Surgical Products 5175 South Royal Atlanta Drive Tucker, GA 30084
Michelle Johnston Contact Person: Telephone: 770-934-8659
Date Prepared: January 7, 1999
DEVICE NAME 2.
Proprietary Name: Common/Usual Name: Classification Name:
SAPHLIFT Surgical instrument holder Manual Surgical Instrument
3. PREDICATE DEVICES
Leonard Arms (K951854) Kronner Low Profile Scope Holder (K973543)
INTENDED USE 4.
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand.
5. DEVICE DESCRIPTION
The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument
1
positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The SAPHLIFT has the same intended use for holding and positioning instruments during surgery, and is substantially equivalent, in terms of technological characteristics, as compared to the predicate devices. The SAPHLIFT and the Kronner devices both have articulated arms that are adjustable by means of ball joints. The Kronner device also incorporates articulated hinges. The Leonard Arms differs slightly in that the instrument is moved by way of a telescoping arm. The SAPHLIFT and Kronner devices both use positive pressure to hold the instrument in place, while the Leonard Arms uses a vacuum. All three devices are reusable after cleaning and sterilization.
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 1999
Ms. Ruth Forstadt Associate Consultant Genzyme Surgical Products c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
K990062 Re: Trade Name: SAPHLIFT Regulatory Class: II Product Code: MDW and GCJ Dated: January 7, 1999 Received: January 8, 1999
Dear Ms. Forstadt:
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 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 (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 equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Ms. Ruth Forstadt
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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/cdrh/dsmamain.html".
Sincerely yours,
S. M. Wee, Ph.D., M.D.
ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): $990000
な Device Name: SAPHLIFT
Indications For Use:
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Poeed
on of General Restorative Device 129900 Xk) Number
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)