(215 days)
- Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.
The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin. The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.
This 510(k) premarket notification (K964252) focuses on establishing substantial equivalence for the ORTHOCHUCK™, a device designed to convert standard keyed metal chuck head surgical drives into keyless chuck drives. The submission primarily relies on a comparison to existing predicate devices rather than independent performance studies with detailed acceptance criteria and standalone performance metrics.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal quantitative acceptance criteria for device performance. Instead, it uses a comparison table to demonstrate how the ORTHOCHUCK™ is functionally equivalent to or improves upon predicate devices. The "reported device performance" is essentially its functional characteristics relative to these predicates.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (OrthoChuck™) |
|---|---|---|
| Intended Use | Must actuate chuck of powered surgical drives. | Actuates chuck of powered surgical drives. (Matches predicate) |
| Method of Operation | Must tighten or loosen chuck jaws. | Spur Gears Turn Sleeve Gear of Chuck. Tightens or Loosens Chuck Jaws. (Matches predicate in function) |
| Effect on Chuck Capacity | Must not alter the existing chuck's capacity. | None. (Matches predicate) |
| Effectiveness | Must tighten or loosen chuck jaws effectively. | Tightens or loosens chuck jaws. (Matches predicate) |
| Ease of Use | Must be easily operable, ideally improving upon keyed chucks. | On-the-fly One Hand, Insert, Tighten or Loosen. (Improved over predicate requiring two hands and drive stopped) |
| Safety (Gloves) | Must reduce risk of glove cuts/pinches compared to keyed chucks. | Eliminates necessity to use usual chuck key, significantly reduces chance that a glove could be cut or pinched in exposed metal gears of chuck and key. |
| Sterility | Must be supplied sterile and maintain sterility during use. | Mfg. Gamma sterilized. Supplied sterile. Disposable (not reusable). |
| Adaptability | Must adapt an existing keyed Jacob's-type chuck to keyless concept. | Adapts an existing keyed Jacob's-type chuck to the keyless concept. |
| Materials | Must be suitable for medical devices and sterilization. | Synthetics (Nylon, Kevlar, glass, Teflon, Carbon fiber, Kraton-G-2705). (Different from metal predicate) |
| Disposable | N/A (a differentiating feature, not an acceptance criterion) | Yes. (Differentiates from reusable metal predicates) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a formal performance study with a "test set" in the sense of clinical or laboratory data for statistical analysis. The determination of substantial equivalence is based on a comparison of design, materials, and intended use with legally marketed predicate devices.
- Sample Size: Not applicable as no specific test set data is presented.
- Data Provenance: Not applicable. The "data" consists of the features and characteristics of the device and its predicate devices, as described in the comparison table and device description.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No external experts were used to establish "ground truth" for a test set, as no test set data was presented. The ground truth, in this context, refers to the established functional characteristics of existing surgical chucks, which are common knowledge in the orthopaedic surgical field. The comparison is made against these known characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring expert adjudication.
5. 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
Not applicable. This device is a mechanical surgical accessory, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The ORTHOCHUCK™ is a mechanical accessory designed to be used by a human surgeon or assistant. It does not operate as an algorithm or autonomously.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" implicitly used for this submission is the established functional performance and safety characteristics of existing legally marketed predicate devices (both keyed and keyless chucks), combined with the detailed design and material specifications of the ORTHOCHUCK™ itself. This reflects an engineering and functional comparison, rather than a clinical outcomes study.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning system, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
{0}------------------------------------------------
Section 510(k) Premarket Notification Summary of Safety and Effectiveness Information
Safe Medical Devices Act of 1990, 21 CFR 807.92 Requiatory Authority: MAY 27 1997
-
ORTHOCHUCK™ 1. Device Trade Name:
-
Common Name: Orthopaedic chuck 2.
-
Classification Name(s): 3.
-
Orthopaedic, AC-Powered Motor and (a) Instrument. Surgical, Accessory-Attachment.
-
(b) Instrument. Surgical, Orthopaedic, DC-Powered Motor and Accessory-Attachment.
-
Instrument, Surgical, Orthopaedic, Pneumatic Powered Motor and (c) Accessory-Attachment.
Establishment Name & Registration Number: 4.
Name: Synergy Medical Products, Inc.
Number: Pendina
5. Classification:
& 878,4820 Surgical instrument motors and accessories or attachments. (a) Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade, (b) Classification. Class I. [55 FR 48440, Nov. 20, 1990]
- Device Class: Class I 6.
-
- Classification Panel:
- (a) General and Plastic Surgery Devices Panel
- (b) Orthopaedic and Rehabilitation Devices Panel
Product Codes(s): 8.
- (a) 87KWE (AC Powered)
- (b) 87KlJ (DC Powered)
- (c) 87HSZ (Pneumatic Powered)
OrthoChuck.doc
محمد المحمد المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول المحمول ال
{1}------------------------------------------------
Contact Person: ය
108 11:42 PM 11:40
Ms. Rhona Porter Synerov Medical Products, Inc. 3001 Redhill Avenue Building 2, Suite 103 Costa Mesa, CA 92626 (714) 825-0240 - (714) 825-0204 - FAX
10. Device Description:
The device is a simple barrel shaped plastic outer sleeve that is designed in such a way that when it is in place over a standard ¼" metal head orthopaedic chuck, it allows the surgeon or assistant to quickly and easily insert, drive and or remove any size (up to ¼" dia.) orthopaedic bit or pin.
The device eliminates the necessity to use the usual chuck key such drives ordinarily require. This feature significantly reduces the chance that a glove could be cut or pinched in the exposed metal gears of the chuck and key. Pin holes in surgical gloves have been shown to a potential source of bacterial and/or viral contamination placing patients and health care providers at risk.
Design: The ORTHOCHUCK™ is made up of the following 6 components:
- The Outer Shell or sleeve forms the outer housing of the device. The Outer Shell contains and retains the remaining components and is the user contact part of the device.
- The Body is that portion of the device that interfaces with the power drive chuck. It also contains 2. and provides the rotational axis for the Face Gear and the Spur Gears.
- The Eace Gear is a cylinder shaped sleeve with a series of circumferential gear teeth. The Face 3. Gear slips over the Body and meshes with and retains the Spur Gears. The outer surface of the Face Gear is provided with a circumferential channel and two locking notches. The channel and locking notches interface with a corresponding pair of linear guides and locking tabs located on the inner surface of the Outer Shell. This feature allows the Face Gear to engage and disengage the chuck teeth by sliding the Outer Shell from a rear (locked) to a forward (unlocked) position on demand.
-
- The Spur Gears are slotted tandem gears having both inner and an outer teeth surrounding a central lumen. The gears fit into 3 !ongitudinal slots in the Body. The Face Gear slides into approximation and locks the Spur Gears into place at the closed end of the 3 longitudinal Body slots.
-
- The Rubber Cap is made from an elastomeric material and is press fit into the end of the Body cylinder. The Rubber Cap is centrally fenestrated and is the centering device through which the selected pins, bits, burs and drills are passed into the drive chuck. The central fenestration stretches as necessary to accommodate different shaft diameter implements.
-
- The three Locking Pins pass through 3 ports in the Outer Shell, through the central lumen of each of the Spur Gears and insert into the 3 drive chuck key holes. Once inserted and broken off they can't be removed non-destructively. The Locking Pins are the mechanisms that secure and actuate the underlying drive chuck via the Spur Gears, tightening and loosening the chuck jaws as desired. Along with the locking tabs of the Outer Shell, the Locking Pins secure the device directly to the drive chuck until destructively removed at the end of the procedure.
{2}------------------------------------------------
Materials:
-
- The Outer Shell or sleeve is made from 6/6 Nylon and 20% Kevlar. The outer shell is either green in color or clear. The clear outer shell is made from medical grade polycarbonate plastic.
- The Body is made from 6/6 Nylon, 20 % glass, 15% Kevlar and 5% Teflon. The Nylon and 2 additional glass and Kevlar provide additional strength and durability while the Teflon acts as a dry lubricant.
- The Face Gear is made from 6/6 Nylon, 20 % glass, 15% Kevlar and 5% Teflon. The Nylon and ကံ additional glass and Kevlar provide additional strength and durability while the Teflon acts as a dry lubricant.
-
- The Spur Gears are made from 6/6 Nylon and 40% Carbon fiber. This particular compound provides additional resistance to wear and has excellent strength characteristics.
- The Rubber Cap is made from Kraton-G-2705. Kraton-G-2705 thermoplastic rubber compound. 5. The material is designed for use in situations requiring FDA compliance. This material is well suited for use in pharmaceutical closures, syringe bulbs and medical devices.
- The Locking Pins are made from 6/6 Nylon, 20 % glass, 15% Kevlar and 5% Teflon. The Nylon 6. and additional glass and Kevlar provide additional strength and durability while the Teflon acts as a dry lubricant.
Packaging:
Packaging materials used are industry standard items. The device system utilizes medical grade nonwoven peel lid vacuum formed tray-type containers. The device is double packaged to allow for sterile transfer of device to operative field.
Sterilization/Re-sterilization:
The device has been Gamma beam sterilized. The radiation dose utilized exceeds the industry standard 2.5 Mirad dose. The sterilization process has been validated and the sterility assurance level is at least 10°. The device must be destructively removed from the power drive after use and thus it can't be reused. If a device is opened and not used, it must be disposed of. The materials used in device construction do not allow for gas or steam resterilization.
11. Device Equivalence:
The equivalence of the device is relatively straight forward, in as much as functional and concept characteristics are concerned. The ORTHOCHUCK™ is intended to replace the existing small metal "T" handled chuck key with a keyless device. In both instances, a secondary device is manipulated to tighten or loosen the jaws of a Jacob's-type chuck. Thus, functionally, the two devices are essentially identical.
The conceptual issue is also easily evaluated, the concept of a keyless chuck is not new. Several keyless chuck systems have been available for more than 50 years and are evidenced by the Collettype chuck, the Hudson-type chuck and the generic two-way pin driver. In all these instances, the devices are primary (not adaptable to the Jacob's-type chuck), and are made from various grades of stainless steel and are reusable.
The difference between the ORTHOCHUCK™ and other keyless chuck designs is the fact that the ORTHOCHUCK™ adapts an existing keyed Jacob's-type chuck to the keyless concept. Additionally, the ORTHOCHUCK™ is supplied sterile and is not reusable.
发专门
{3}------------------------------------------------
A Comparison table is presented below that graphically demonstrates the important comparison features of selected keyed and keyless devices.
12. Comparison Table
| FEATURE | OrthoChuck | Jacob's ChuckW/ Key | Two-Way PinDriver | SE? |
|---|---|---|---|---|
| Materials: | Synthetics | Metal | Metal | No |
| Intended Use(s): | Actuate Chuck ofPowered SurgicalDrives | Same | Same | Yes |
| Design: | Cylindrical Sleeve | "T" Shaped Key | Cylindrical Sleeve | Yes |
| Method of Operation: | Spur Gears TurnSleeve Gear ofChuck | Same | Same | Yes |
| Disposable: | Yes | No | No | No |
| Effect on Chuck Capacity: | None | None | None | Yes |
| Ease of Use: | On-the-fly OneHand, Insert,Tighten or Loosen | Drive Stopped -Two HandsRequired | Drive Stooped -Two HandsRequired | No |
| Effectiveness: | Tightens orLoosens ChuckJaws | Tightens orLoosens ChuckJaws | Tightens orLoosens ChuckJaws | Yes |
| How Sterilized: | Mfg. Gamma | User - Steam | User - Steam | Yes |
| 510(k) Status: | 510(k) Required | 510(k) Exempt | 510(k) Exempt | NA |
| K Number | NA | Preamendment | Preamendment | NA |
OrthoChuck.doc
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUM SERVICES - USA" are arranged around the caduceus in a circular fashion. The image is black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synergy Medical Products, Inc. c/o Mr. David W. Schlerf Buckman Company 1000 Burnett Avenue, Suite 450 Concord, California 94520
MAY 27 1997
Re: K964252 Trade Name: OrthoChuck™ Regulatory Class: I Product Code: GEY Dated: February 21, 1997 Received: February 26, 1997
Dear Mr. Schlerf:
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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
{5}------------------------------------------------
Page 2 - Mr. David W. Schlerf
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Page 1 of _ 在线体
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ : |
Indications For Use:
-
- Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Not with Electrice of CDRH, Office of Device Evaluation (ODE)
- Converts Ail Standard Keyed Metal Chuck Head Surgical Drives Into Keyless Chuck Drives.
tcooo
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K914252
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional format 1-2-96)
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(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 § 878.9.